Effect of propofol combined with opioids on cough reflex suppression in gastroscopy: study protocol for a double-blind randomized controlled trial

IntroductionThe best methods for inducing analgesia and sedation for gastroscopy are still debated but finding an adequate regimen of sedation/analgesia is important. Stimulation of the larynx under sedation can cause reflex responses. Propofol with opioids has been recommended for gastroscopy sedation but the effects on cough reflex suppression remain unclear. This trial will evaluate the effects of propofol combined with small doses of dezocine, oxycodone, sufentanil or fentanyl for gastroscopy. We hypothesise that better performance may be obtained with a combination of propofol and oxycodone. We will observe the incidence and degree of reflex coughing and gagging under sedation when using propofol combined with one of the above drugs or propofol alone.Methods and analysisThis will be a prospective, randomised, double-blind, controlled trial. ASA I–II level patients aged 18–65 years and scheduled for gastroscopy will be included. It is planned that 500 subjects will be randomised to intravenously receive 2–2.2 mg/kg propofol plus 0.5–0.8 μg/kg fentanyl (fentanyl group), 2–2.2 mg/kg propofol plus 0.05–0.08 μg/kg sufentanil (sufentanil group), 2–2.2 mg/kg propofol plus 0.04–0.05 mg/kg dezocine (dezocine group), 2–2.2 mg/kg propofol plus 0.04–0.05 mg/kg oxycodone (oxycodone group), or 2.4–3 mg/kg propofol plus 2–2.5 mL saline (control group) for sedation. The primary endpoint is the incidence and degree of reflex coughing and gagging. The secondary endpoints include the occurrence of discomfort or side effects, the use of jaw thrust, assisted ventilation or additional propofol, recovery time, duration of procedure and Steward score.Ethics and disseminationThis study has been approved by the Institutional Ethics Committee for Clinical Research of Zhongda Hospital, Affiliated to Southeast University (No. 2015ZDSYLL033.0). The results of the trial will be published in an international peer-reviewed journal.Trial registrationThis study has been registered with the Chinese Clinical Trial Register (No. ChiCTR-ICR-15006952).Trial statusAt the time of manuscript submission, the study was in the recruitment phase.

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Does Epidural Anesthesia Have General Anesthetic Effects?

Anesthesiology ◽

10.1097/00000542-199912000-00021 ◽

1999 ◽

Vol 91 (6) ◽

pp. 1687-1687 ◽

Cited By ~ 101

Author(s):

Peter S. Hodgson ◽

Spencer S. Liu ◽

Troy W. Gras

Keyword(s):

General Anesthesia ◽

Epidural Anesthesia ◽

Controlled Trial ◽

Saline Control ◽

Control Group ◽

Double Blind ◽

Lidocaine Group ◽

Group I ◽

End Tidal ◽

Volatile Agents

Background Clinically, patients require surprisingly low end-tidal concentrations of volatile agents during combined epidural-general anesthesia. Neuraxial anesthesia exhibits sedative properties that may reduce requirements for general anesthesia. The authors tested whether epidural lidocaine reduces volatile anesthetic requirements as measured by the minimum alveolar concentration (MAC) of sevoflurane for noxious testing cephalad to the sensory block. Methods In a prospective, randomized, double-blind, placebo-controlled trial, 44 patients received 300 mg epidural lidocaine (group E), epidural saline control (group C), or epidural saline-intravenous lidocaine infusion (group I) after premedication with 0.02 mg/kg midazolam and 1 microg/kg fentanyl. Tracheal intubation followed standard induction with 4 mg/kg thiopental and succinylcholine 1 mg/kg. After 10 min or more of stable end-tidal sevoflurane, 10 s of 50 Hz, 60 mA tetanic electrical stimulation were applied to the fifth cervical dermatome. Predetermined end-tidal sevoflurane concentrations and the MAC for each group were determined by the up-and-down method and probit analysis based on patient movement. Results MAC of sevoflurane for group E, 0.52+/-0.18% (+/- 95% confidence interval [CI]), differed significantly from group C, 1.18+/-0.18% (P < 0.0005), and from group I, 1.04+/-0.18% (P < 0.001). The plasma lidocaine levels in groups E and I were comparable (2.3+/-1.0 vs. 3.0+/-1.2 microg/ml +/- SD). Conclusions Lidocaine epidural anesthesia reduced the MAC of sevoflurane by approximately 50%. This MAC sparing is most likely caused by indirect central effects of spinal deafferentation and not to systemic effects of lidocaine or direct neural blockade. Thus, lower concentrations of volatile agents than those based on standard MAC values may be adequate during combined epidural-general anesthesia.

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Intrauterine levobupivacaine for pain control during intrauterine device insertion

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20170596 ◽

2017 ◽

Vol 6 (3) ◽

pp. 1117

Author(s):

Nilufer Akgun ◽

Esra Keskin ◽

Muberra Namlı Kalem ◽

Batuhan Bakirarar

Keyword(s):

Pain Control ◽

Controlled Trial ◽

Intrauterine Device ◽

Saline Control ◽

Control Group ◽

Double Blind ◽

Pain Scores ◽

Significant Difference ◽

Vas Scores

Background: Safe, effective, long term and a reversible contraception method is offered by intrauterine devices (IUDs). The objective was to determine the potency of intrauterine administration of 5 cc levobupivacain for pain relief with IUD insertion, when compared with saline placebo.Methods: This was a prospective randomized, double blind placebo-controlled trial undergoing İUD insertion. The trial medication was intrauterine anesthesia, either 5 mL 0.9% saline (control group), or 5 mL 0.5% levobupivacaine. Our primary outcome was self-reported pain scores on a 10 cm visual analogue scale (VAS) immediately following IUD insertion.Results: 95 women were enrolled, and data for 88 women were analyzed. In IUD insertion procedure, no difference was observed between groups during teneculum placement and solution administration, in the course of VAS scores (p=0.349, p=0.396). There was a significant difference in the VAS scores measuring pain suffering during and after IUD procedure (p=0.001).Conclusions: Intrauterine instillation of 5 cc of levobupivacaine along with saline solution reduces pain with IUD insertion when compared to intrauterine saline placebo. Broad deviation in pain scores and persistent pain after IUD insertion recommends that patient would benefit from more functioning method of pain control than before at IUD insertion and during the post interval.

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Intravenous Esmolol Infusion Improves Surgical Fields during Sevoflurane-Anesthetized Endoscopic Sinus Surgery: A Double-Blind, Randomized, Placebo-Controlled Trial

American Journal of Rhinology and Allergy ◽

10.2500/ajra.2011.25.3701 ◽

2011 ◽

Vol 25 (6) ◽

pp. e208-e211 ◽

Cited By ~ 16

Author(s):

Ping-Hung Shen ◽

Erik Kent Weitzel ◽

Jen-Tsung Lai ◽

Peter-John Wormald ◽

Chee-Sang Ho

Keyword(s):

Blood Pressure ◽

Blood Loss ◽

Endoscopic Sinus Surgery ◽

Controlled Trial ◽

Sinus Surgery ◽

Constant Infusion ◽

Saline Control ◽

Control Group ◽

Double Blind ◽

The Impact

Background There is increasing evidence to support the use of anesthetics to affect operative fields during endoscopic sinus surgery and thus the speed, thoroughness, and safety of the surgery itself. Previous research has suggested preoperative beta-blockers improve surgical fields (SFs); our study is novel in showing the impact of a beta-blocker infusion on SFs during sinus surgery. Methods A prospective, randomized, double-blind, placebo-controlled trial was conducted in 40 patients. Patients undergoing endoscopic sinus surgery for chronic rhinosinusitis received a constant infusion of i.v. esmolol or saline in addition to a standard inhaled anesthetic protocol. At regular 15-minutes intervals, the quality of SF, heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP) were assessed. Total blood loss was also recorded. Results Average vital sign parameters (HR/SBP/DBP) were significantly lower in the esmolol group (69.1/90.2/55.1 versus 77.2/99.5/63.5; p < 0.01). The esmolol infusion improved SFs relative to control (2.3 versus 2.6; p = 0.045). Esmolol infusion resulted in good SFs (grades 1 and 2) more often than poor fields (grades 3 and 4); on the contrary, the control group showed more poor than good SFs (chi-square; p = 0.04). A correlation between increasing HR and worsening SFs was identified (r = 0.259; p = 0.002). The control group had significantly higher average blood loss (1.3 versus 0.8 mL/min; p = 0.037). Conclusion Esmolol-induced relative hypotension and bradycardia during endoscopic sinus surgery achieves significantly improved SFs relative to saline control.

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Dexmedetomidine vs. lidocaine for postoperative analgesia in pediatric patients undergoing craniotomy: a protocol for a prospective, randomized, double-blinded, placebo-controlled trial

Trials ◽

10.1186/s13063-021-05774-9 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Yuan Zhang ◽

Di Bao ◽

Dongmei Chi ◽

Lu Li ◽

Bin Liu ◽

...

Keyword(s):

Postoperative Pain ◽

Postoperative Analgesia ◽

Pediatric Patients ◽

Pediatric Population ◽

Controlled Trial ◽

Intervention Group ◽

Saline Control ◽

Control Group ◽

Double Blind ◽

Double Blinded

Abstract Background Postoperative pain is a common problem that occurs in pediatric patients following neurosurgery which may lead to severe complications. Dexmedetomidine is a commonly used adjuvant medicine in craniotomy owing to its sedative, amnestic, analgesic, and neuroprotective properties. Besides, studies suggest that lidocaine has similar effects on sedation, analgesia, and neuroprotection. Both two adjuvants can reduce postoperative pain after neurosurgery in adults. However, it is still unknown whether dexmedetomidine or lidocaine can reduce postoperative pain in children undergoing craniotomy, and if yes, which is a better medicine choice. Therefore, we aimed to compare the effect of dexmedetomidine vs. lidocaine on postoperative pain in pediatric patients after craniotomy. Methods/design We will perform a randomized (1:1:1), double-blind, placebo-controlled, single-center trial. Children aged 1–12 years scheduled for craniotomy will be eligible for inclusion. The 255 recruited participants will be stratified by age in two strata (1–6 years and 7–12 years), and then each stratum will be equally randomized to three groups: group D (infusion of dexmedetomidine [intervention group]), group L (infusion of lidocaine [intervention group]), and group C (infusion of normal saline [control group]). Patients will be followed up at 1 h, 2 h, 4 h, 24 h, and 48 h after surgery. The primary outcome will be total sufentanil consumption within 24 h after surgery. Discussion In this clinical trial, we expect to clarify and compare the postoperative analgesic effect of dexmedetomidine vs. lidocaine infusion on pediatric patients undergoing craniotomy. We believe that the results of this trial will provide more choices for postoperative analgesia for the pediatric population. Trial registration Chinese ClinicalTrials.gov ChiCTR1800019411. Registered on 10 November 2018

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Dexmedetomidine Versus Lidocaine for Postoperative Analgesia in Pediatric Patients Undergoing Craniotomy: a Protocol for a Prospective, Randomized, Double-blinded, Placebo-controlled Trial

10.21203/rs.3.rs-414384/v1 ◽

2021 ◽

Author(s):

Yuan Zhang ◽

Di Bao ◽

Dongmei Chi ◽

Lu Li ◽

Bin Liu ◽

...

Keyword(s):

Postoperative Pain ◽

Postoperative Analgesia ◽

Pediatric Patients ◽

Pediatric Population ◽

Controlled Trial ◽

Intervention Group ◽

Saline Control ◽

Control Group ◽

Double Blind ◽

Double Blinded

Abstract Background: Postoperative pain is a common problem that occurs in pediatric patients following neurosurgery which may lead to severe complications. Dexmedetomidine is a commonly used adjuvant medicine in craniotomy owing to its sedative, amnestic, analgesic, and neuroprotective properties. Besides, studies suggest that lidocaine has similar effects on sedation, analgesia, and neuroprotection. Both two adjuvants can reduce postoperative pain after neurosurgery in adults. However, it is still unknown whether dexmedetomidine or lidocaine can reduce postoperative pain in children undergoing craniotomy and if yes, which is a better medicine choice. Therefore, we aimed to compare the effect of dexmedetomidine vs. lidocaine on postoperative pain in pediatric patients after craniotomy. Methods/design: We will perform a randomized (1:1:1), double-blind, placebo-controlled, single-center trial. Children aged 1–12 years scheduled for craniotomy will be eligible for inclusion. The 255 recruited participants will be stratified by age in two strata (1–6 years and 7–12 years), and then each stratum will be equally randomized to three groups: Group D (infusion of dexmedetomidine [intervention group]), Group L (infusion of lidocaine [intervention group]), and Group C (infusion of normal saline [control group]). Patients will be followed-up at 1 h, 2 h, 4 h, 24 h, and 48 h after surgery. The primary outcome will be total sufentanil consumption within 24 h after surgery.Discussion: In this clinical trial, we expect to clarify and compare the postoperative analgesic effect of dexmedetomidine vs. lidocaine infusion on pediatric patients undergoing craniotomy. We believe that the results of this trial will provide more choices for postoperative analgesia for the pediatric population.Trial registration: Chinese ClinicalTrials.gov Identifier: ChiCTR1800019411. Registered 10 November 2018. Registered with the name of “A randomized double-blind controlled trial for low-dose dexmedetomidine and lidocaine in the treatment of post-craniotomy pain in children” URL: http://www.chictr.org.cn/showproj.aspx?proj=32822

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Comparison of Lidocaine, Huffing Maneuver and Combination of Both in Prevention Fentanyl Induced Cough Before Induction of Anesthesia: A Randomized Placebo-Controlled Trial

10.21203/rs.3.rs-174791/v1 ◽

2021 ◽

Author(s):

Laleh Dehghanpisheh ◽

Mohammadhossein Eghbal ◽

Fatemeh Bagheri Baravati ◽

Pooya Vatankhah

Keyword(s):

Controlled Trial ◽

Trial Registration ◽

Control Group ◽

Anesthesia Induction ◽

Lidocaine Group ◽

Cough Reflex ◽

Group 4 ◽

Significant Difference ◽

Group 2 ◽

Group 1

Abstract Background Intravenous bolus injection of fentanyl has been frequently reported to be associated with cough reflex during patient anesthesia. However, the search for the most effective protocol continues. This study aimed to compare the effect of reducing cough reflex after injection of fentanyl in a fusion protocol by combining the injections of lidocaine and Huffing maneuver and comparing with a placebo control group, before anesthesia induction. Methods This prospective randomized controlled trial study was performed on 400 patients who were divided into four groups of combined protocol (group 1), lidocaine group (group 2), Huffing maneuver group (group 3), and the control receiving normal saline (group 4). Then patients were injected with 2. 5 µg /kg fentanyl and monitored for two minutes regarding their cough reflex, as well as the severity. Results In group 1, 9 patients (9%), in group 2, 22 patients (22%), in the group3 45 patients (45%) and in the group 4, 75 patients (75%), developed cough reflex following fentanyl injection. Also, 13 patients (13%) developed moderate and 4 (4%) developed severe coughs in the control group reported, while no reports of severe or moderate cough were among the intervention groups. There was a significant difference between the intervention group and the control group both in terms of the rate and severity of the fentanyl-induced cough. Conclusion By using a combination of lidocaine injection along and Huffing maneuver, better results can be obtained in reducing the frequency, and also the severity of cough followed by fentanyl injection. Trial registration: Trial Registration: The trial was registered with IRCT.IR (09/03/2018-No. IRCT20141009019470N74).

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Comparison of lidocaine, huffing maneuver and combination of both in prevention fentanyl induced cough before induction of anesthesia: a double-blind, prospective, randomized placebo-controlled study

BMC Anesthesiology ◽

10.1186/s12871-021-01313-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Laleh Dehghanpisheh ◽

Mohammadhossein Eghbal ◽

Fatemeh Bagheri Baravati ◽

Pooya Vatankhah

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Placebo Control ◽

Anesthesia Induction ◽

Double Blind ◽

Lidocaine Group ◽

Cough Reflex ◽

Significant Difference

Abstract Background Intravenous bolus injection of fentanyl has been frequently reported to be associated with cough reflex during patient anesthesia. However, the search for the most effective protocol continues. This study aimed to compare the effect of reducing cough reflex after injection of fentanyl in a fusion protocol by combining the injections of lidocaine and Huffing maneuver and comparing with a placebo control group, before anesthesia induction. Methods This prospective randomized controlled trial study was performed on 400 patients who were divided into four groups of combined protocol (group 1), lidocaine group (group 2), Huffing maneuver group (group 3), and the control receiving normal saline (group 4). Then patients were injected with 2. 5 μg /kg fentanyl and monitored for 2 min regarding their cough reflex, as well as the severity. Results In group one, 9 patients (9%), in group two, 45 patients (45%), 22 patients (22%) in group three, and in group four, 75 patients (75%), developed cough reflex following fentanyl injection. Also, 13 patients (13%) developed moderate and 4 (4%) developed severe coughs in the control group reported, while no reports of severe or moderate cough were among the intervention groups. There was a significant difference between the intervention group and the control group both in terms of the rate and severity of the fentanyl-induced cough. Conclusion By using a combination of lidocaine injection along and Huffing maneuver, better results can be obtained in reducing the frequency, and also the severity of cough followed by fentanyl injection. Trial registration The trial was registered with IRCT.IR (09/03/2018-No. IRCT20141009019470N74).

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Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽

10.1177/0333102421989232 ◽

2021 ◽

Vol 41 (3) ◽

pp. 294-304 ◽

Cited By ~ 2

Author(s):

Messoud Ashina ◽

Uwe Reuter ◽

Timothy Smith ◽

Judith Krikke-Workel ◽

Suzanne R Klise ◽

...

Keyword(s):

Controlled Trial ◽

Study Drug ◽

Statistical Testing ◽

Control Group ◽

Double Blind ◽

Treatment Groups ◽

Primary Endpoints ◽

Registration Number ◽

Secondary Endpoints ◽

Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

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Single High-Dose Vitamin D Supplementation as an Approach for Reducing Ultramarathon-Induced Inflammation: A Double-Blind Randomized Controlled Trial

Nutrients ◽

10.3390/nu13041280 ◽

2021 ◽

Vol 13 (4) ◽

pp. 1280

Author(s):

Jan Mieszkowski ◽

Andżelika Borkowska ◽

Błażej Stankiewicz ◽

Andrzej Kochanowicz ◽

Bartłomiej Niespodziński ◽

...

Keyword(s):

Vitamin D ◽

Inflammatory Marker ◽

Controlled Trial ◽

Vitamin D Supplementation ◽

Oncostatin M ◽

Control Group ◽

High Dose ◽

Double Blind ◽

Single High Dose ◽

High Dose Vitamin

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.

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Consumption of a Double-Fortified Salt Affects Perceptual, Attentional, and Mnemonic Functioning in Women in a Randomized Controlled Trial in India

Journal of Nutrition ◽

10.3945/jn.117.251587 ◽

2017 ◽

Vol 147 (12) ◽

pp. 2297-2308 ◽

Cited By ~ 6

Author(s):

Michael J Wenger ◽

Laura E Murray-Kolb ◽

Julie EH Nevins ◽

Sudha Venkatramanan ◽

Gregory A Reinhart ◽

...

Keyword(s):

Iron Deficiency ◽

Iron Status ◽

Controlled Trial ◽

Reproductive Age ◽

Deficiency Anemia ◽

Control Group ◽

Attention And Memory ◽

Double Blind ◽

Iron Deficient ◽

Mnemonic Function

Abstract Background: Iron deficiency and iron deficiency anemia have been shown to have negative effects on aspects of perception, attention, and memory. Objective: The purpose of this investigation was to assess the extent to which increases in dietary iron consumption are related to improvements in behavioral measures of perceptual, attentional, and mnemonic function. Methods: Women were selected from a randomized, double-blind, controlled food-fortification trial involving ad libitum consumption of either a double-fortified salt (DFS) containing 47 mg potassium iodate/kg and 3.3 mg microencapsulated ferrous fumarate/g (1.1 mg elemental Fe/g) or a control iodized salt. Participants' blood iron status (primary outcomes) and cognitive functioning (secondary outcomes) were assessed at baseline and after 10 mo at endline. The study was performed on a tea plantation in the Darjeeling district of India. Participants (n = 126; 66% iron deficient and 49% anemic at baseline) were otherwise healthy women of reproductive age, 18–55 y. Results: Significant improvements were documented for iron status and for perceptual, attentional, and mnemonic function in the DFS group (percentage of variance accounted for: 16.5%) compared with the control group. In addition, the amount of change in perceptual and cognitive performance was significantly (P < 0.05) related to the amount of change in blood iron markers (mean percentage of variance accounted for: 16.0%) and baseline concentrations of blood iron markers (mean percentage of variance accounted for: 25.0%). Overall, there was evidence that the strongest effects of change in iron status were obtained for perceptual and low-level attentional function. Conclusion: DFS produced measurable and significant improvements in the perceptual, attentional, and mnemonic performance of Indian female tea pickers of reproductive age. This trial was registered at clinicaltrials.gov as NCT01032005.

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