scholarly journals Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhaoyan Feng ◽  
Xiao Shi ◽  
Xue Yan ◽  
Yamin Zhu ◽  
Juan Gu ◽  
...  

Abstract Background Emergence agitation (EA) after general anesthesia is a common complication in the post-anesthesia care unit (PACU). Once EA occurs, there are still no guidelines established for the treatment in adults. Propofol is excessively used in managing agitated patients in the PACU, but it lacks analgesia and can result in apnea. Intraoperative infusion of dexmedetomidine has been proven to have a preventive effect on EA, but the treatment effect of dexmedetomidine on EA remains unknown. This study aims to compare the effects between dexmedetomidine and propofol on relieving EA in adult patients after general anesthesia in the PACU. Methods In this randomized, superiority, controlled clinical study, a total of 120 adult patients aged 18–65 years of both genders, with American Society of Anesthesiologists (ASA) classification I or II developing EA in the PACU after general anesthesia, will be enrolled. Patients will be randomized at a 1:1 ratio into two groups, receiving either a single dose of dexmedetomidine (0.7μg/kg) or propofol (0.5 mg/kg). The primary outcome is the proportion of patients having a recurrent EA within 15 min after intervention in the PACU. Discussion Previous studies have focused on premedication for preventing EA, while therapeutics for reliving EA have rarely been reported. To our knowledge, this study is the first randomized, superiority, controlled trial to compare a bolus of dexmedetomidine with the current routine care for this indication. Trial registration ClinicalTrials.govNCT04142840. Registered on October 26, 2019

2020 ◽  
Author(s):  
Atef Mohamed Sayed Mahmoud ◽  
Joseph Makram Botros ◽  
Safaa Gaber Ragab

Abstract Background the outcome of ketofol on the hemodynamics and the airway response during induction of general anesthesia has been studied before. Its effect on smoothness of extubation has not been studied before. So, we aimed to assess the effect of ketofol on the smoothness of extubation and compare it with propofol only for induction of general anesthesia. Methods This double-blind, randomized, and controlled study was conducted on one hundred and six American Society of Anesthesiologists Physical status ''ASA PS'' class I and II female patients aged 18–40 years old and scheduled for laparoscopic drilling for polycystic ovary disease under general anesthesia. The patients were assigned into one of two groups (53) patients each; group KP = ketofol and group P = propofol. Results There was good sedation score during suction and extubation in the ketofol group. Airway response and smoothness of extubation were better in the ketofol group better than the propofol group. Conclusion Ketofol as an induction anesthetic agent was effective in attenuating the airway response during extubation more than profofol only. Trial registration: This trial was retrospectively registered at the Clinical Trial.gov with the Identification Number: NCT04365686.


2018 ◽  
Vol 46 (5) ◽  
pp. 1839-1845
Author(s):  
Wei Wang ◽  
Jie Lv ◽  
Qi Wang ◽  
Lei Yang ◽  
Wanyou Yu

Objective This study was performed compare the effectiveness of oxycodone and fentanyl in reducing the incidence and severity of etomidate-induced myoclonus. Methods In total, 162 patients with an American Society of Anesthesiologists physical status of I or II were assigned at random to three groups. Patients assigned to Group O received 0.1 mg/kg of oxycodone (n = 54), those assigned to Group F were given 1 µg/kg of fentanyl (n = 54), and those assigned to Group S were given an equal volume of saline intravenously 2 minutes prior to administration of 0.3 mg/kg of etomidate (n = 54). The incidence and severity of myoclonus was evaluated 2 minutes after etomidate administration. The patients’ vital signs, coughing, nausea, dizziness, and other related adverse reactions were also recorded. Results The incidence of myoclonus was significantly lower in Group O (0.0%) than in Group F (31.5%) and Group S (72.2%); the intensity was also lowest in Group O. All patients in each group had stable cardiovascular profiles. Conclusions Intravenous injection of 0.1 mg/kg of oxycodone 2 minutes prior to etomidate is more effective in preventing etomidate-induced myoclonus during general anesthesia than is 1 µg/kg of fentanyl.


2021 ◽  
Author(s):  
Zhaoyan Feng ◽  
Xiao Shi ◽  
Xue Yan ◽  
Yamin Zhu ◽  
Juan Gu ◽  
...  

Abstract BackgroundEmergence agitation (EA) from general anesthesia is a common complication in the post anesthesia care unit (PACU). Once EA happens, there is still no guidelines established to recommend the medication administration in adults. Propofol is widely used in managing agitated patient in the PACU, but it is lack of analgesia and can suppress breathing transiently. Intraoperative infusion of dexmedetomidine is proved to have preventive effect on EA, but the treatment effect of dexmedetomidine on EA occurring in the PACU remains unknown. This study aims to compare the effects between dexmedetomidine and propofol on relieving emergence agitation in the PACU in adult patients after general anesthesia. MethodsIn this randomized, controlled, single-blinded clinical study, a total of 120 adult patients aged 18-65 years of both genders, with American Society of Anesthesiologists (ASA) classification I or II who develop emergence agitation in the PACU after general anesthesia will be included. Patients will be randomized at 1:1 ratio to two groups, receiving either a single dose of dexmedetomidine (0.7ug/kg) or propofol (0.5mg/kg). The primary outcome is the recurrence rate of EA assessed by the Riker Sedation-Agitation Scale (RSAS). The secondary outcomes are RSAS scores and vital signs before and after intervention, the consumption of sufentanil in the PACU, nausea and vomiting scores evaluated by a four-point postoperative nausea and vomiting (PONV) scale when leaving the PACU, duration in the PACU, adverse events (desaturation, severe bradycardia, shivering, dizziness, laryngospasm, severe coughing, reintubation) and recovering quality evaluated by the 40-item quality of recovery scale (Qo-R 40).DiscussionPrevious studies are almost about the efficacy of premedication on preventing EA, while medicine administration on treating EA is reported rarely. This study is designed to investigate whether a single dose of dexmedetomidine can relieve EA more efficiently and improve recovery quality of adult patients form general anesthesia more significantly comparing to propofol.Trial registrationClinicalTrials.gov ID: NCT04142840.Registered on October 26, 2019. https://clinicaltrials.gov/ct2/show/NCT04142840.


2020 ◽  
Author(s):  
Atef Mohamed Sayed Mahmoud ◽  
Safaa Gaber Ragab ◽  
Joseph Makram Botros

Abstract Background : the outcome of ketofol on the hemodynamics and the airway response during induction of general anesthesia has been studied before. Its effect on the smoothness of extubation has not been studied before. So, we aimed to assess the effect of ketofol on the smoothness of extubation and compare it with propofol only for the induction of general anesthesia. Methods: This double-blind, randomized, and controlled study was conducted on one hundred and six American Society of Anesthesiologists Physical status ''ASA PS'' class I and II female patients aged 18-40 years old and scheduled for laparoscopic drilling for polycystic ovary disease under general anesthesia. The patients were assigned into one of two groups (53) patients each; group KP = ketofol and group P = propofol. Results: There was a good sedation score during suction and extubation in the ketofol group. Airway response and smoothness of extubation were better in the ketofol more than the propofol group. Conclusion: Ketofol as an induction anesthetic agent was effective in attenuating the airway response during extubation more than profofol only. Trial registration: This trial was retrospectively registered at the Clinical Trial.gov with the Identification Number: NCT04365686.


2020 ◽  
Author(s):  
Atef Mohamed Sayed Mahmoud ◽  
Safaa Gaber Ragab ◽  
Joseph Makram Botros

Abstract Background: The impact of ketofol on the hemodynamics and the airway response during the induction of general anesthesia has been studied before. However, its effect on the smoothness of extubation has not been studied before. Thus, we aimed to assess the effect of ketofol on the smoothness of extubation and compare it with propofol for the induction of general anesthesia.Methods: This double-blind, randomized, and controlled study was conducted on 106 class I and II female patients with the “American Society of Anesthesiologists Physical Status (ASA PS),” aged 18–40 years and scheduled for laparoscopic drilling for polycystic ovary disease under general anesthesia. The patients were assigned to one of two groups of (53) patients each; group KP = ketofol and group P = propofol. Results: There was a good sedation score during suction and extubation in the ketofol group. Airway response and smoothness of extubation were better in the ketofol than in the propofol group.Conclusion: Ketofol as an induction anesthetic agent was effective in attenuating the airway response during extubation more than only propofol.Trial registration: This trial was retrospectively registered at the Clinical Trial.gov with the Identification Number: NCT04365686.


2020 ◽  
Author(s):  
Pinping Zhou ◽  
Chao Zhang ◽  
Guijin Huang ◽  
Yuan Hu ◽  
Wenzhu Ma ◽  
...  

Abstract Background: Dental procedures under general anesthesia (DGA) was found to improve the oral health-related quality of children's life. However, some parents and pediatricians expressed concern about the neurotoxicity of general anesthesia. The purpose of this trial was to investigate whether DGA in children has an adverse effect on neurodevelopment.Methods: In this prospective, assessor-masked, controlled, equivalence trial, we recruited 340 children younger than 7 years who were undergoing caries treatment between Feb 1, 2019, and Aug 31, 2019, without factors affecting neurodevelopment. They received either sevoflurane-based general anesthesia or awake-local anesthesia. The Wechsler Preschool and Primary Scale of Intelligence-Fourth Edition was used to evaluate the neurodevelopment of children at six months after surgery, and the Full-Scale IQ (FSIQ) was selected as the primary outcome. Predefine the 95% CI of a difference in means within five (1/3 SD) as the equivalence margin.Results: The outcome data were obtained from 129 children in the general anesthesia group and 144 in the local anesthesia group. The median length of general anesthesia was 130 min (IQR 110 – 160). There was equivalence in means of FSIQ score between the general anesthesia group and the local anesthesia group (local minus general anesthesia 0.46, 95% CI -2.35 to 1.61). There was no significant difference in FSIQ scores between different age groups and different anesthesia durations. Only the mother's education could affect the primary outcome.Conclusions: In this trial, prolonged DGA with a sevoflurane-only anesthetic in preschool children, does not adversely affect neurodevelopment at six months after surgery compared with awake-local anesthesia. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800015216. Registered Mar 15 2018, http://www.chictr.org.cn/showproj.aspx?proj=24830.


Author(s):  
Dang Tinh Pham ◽  
Thi Ngoc Le ◽  
Ton Ngoc Vu Phan ◽  
Parshal Bhandari ◽  
Sairah Zia ◽  
...  

OBJECTIVE The aim of this study was to access the influence of active warming after epidural anesthesia (EDA) and before general anesthesia in prevention of perioperative hypothermia. METHOD This randomized controlled trial was conducted in the department of anesthesiology in university medical center of Ho Chi Minh city, Vietnam from December 2019 until April 2020. This trial included 60 adult patients who were scheduled for major abdominal surgery with a duration of at least 120 minutes and under combined general anesthesia and EDA. Patients were excluded if age was below 18 years, American Society Anesthesiologists’ physical status classification of IV or higher, or refusal of EDA. Written informed consent was obtained for all patients. Patients were divided randomly into two groups. The first group received 10 minutes of active air-forced warming after EDA before the induction of general anesthesia. The second group was covered with a blanket 10 minutes after EDA and before general anesthesia. Core temperatures were recorded throughout the study. The primary outcome measures were the incidence of perioperative hypothermia and the degree of hypothermia. The secondary outcome measures were rate and time for body temperature to return to normal and incidence of postoperative body shivering. RESULTS Without active warming (n = 21), 70% of patients became hypothermic (<36°C) postoperatively. Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia decreased the incidence of postoperative hypothermia to 26.7% (n = 8). CONCLUSION Active air-forced warming for 10 minutes after EDA and before induction of general anesthesia is efficient in reducing the incidence of perioperative hypothermia.


2017 ◽  
Vol 127 (1) ◽  
pp. 50-57 ◽  
Author(s):  
Jessica L. Booth ◽  
Vernon H. Ross ◽  
Kenneth E. Nelson ◽  
Lynnette Harris ◽  
James C. Eisenach ◽  
...  

Abstract Background The addition of opioids to epidural local anesthetic reduces local anesthetic consumption by 20% but at the expense of side effects and time spent for regulatory compliance paperwork. Epidural neostigmine also reduces local anesthetic use. The authors hypothesized that epidural bupivacaine with neostigmine would decrease total hourly bupivacaine use compared with epidural bupivacaine with fentanyl for patient-controlled epidural analgesia. Methods A total of 215 American Society of Anesthesiologists physical status II, laboring parturients requesting labor epidural analgesia consented to the study and were randomized to receive 0.125% bupivacaine with the addition of either fentanyl (2 μg/ml) or neostigmine (2, 4, or 8 μg/ml). The primary outcome was total hourly local anesthetic consumption, defined as total patient-controlled epidural analgesia use and top-ups (expressed as milliliters of 0.125% bupivacaine) divided by the infusion duration. A priori analysis determined a group size of 35 was needed to have 80% power at α = 0.05 to detect a 20% difference in the primary outcome. Results Of 215 subjects consented, 151 patients were evaluable. Demographics, maternal and fetal outcomes, and labor characteristics were similar among groups. Total hourly local anesthetic consumption did not differ among groups (P = 0.55). The total median hourly bupivacaine consumption in the fentanyl group was 16.0 ml/h compared with 15.3, 14.6, and 16.2 ml/h in the 2, 4, and 8 μg/ml neostigmine groups, respectively (P = 0.55). Conclusions The data do not support any difference in bupivacaine requirements for labor patient-controlled epidural analgesia whether patients receive epidural bupivacaine with 2 to 8 μg/ml neostigmine or epidural bupivacaine with 2 μg/ml fentanyl.


2014 ◽  
Vol 32 (3) ◽  
pp. 223-226 ◽  
Author(s):  
Zhaodi Zhang ◽  
Changsong Wang ◽  
Quanyi Li ◽  
Mingyue Zhang ◽  
Haifang Zhao ◽  
...  

Objectives To evaluate whether electroacupuncture (EA) at ST36 can accelerate the recovery of gastrointestinal motility after colorectal surgery. Methods Forty patients of American Society of Anesthesiologists physical status II and III undergoing elective open resection of malignant colorectal tumours were included in this study. Using a sealed envelope method, the patients were randomly divided into two groups either receiving EA (EA group) or sham EA (SEA group). Data regarding the recovery of bowel function (times to the first bowel sounds, passage of flatus and defaecation) were collected and analysed. Results In the EA group, the time intervals from surgery to the first bowel movement and passage of flatus were shorter than in the SEA group (13±10 h vs 19±13 h, p<0.05 and 23±14 h vs 32±18 h, p<0.05, respectively). There was no significant difference between the groups regarding the time to first defaecation (68±45 h vs 72±53 h, p>0.05). Conclusions EA at ST36 accelerates the recovery of gastrointestinal motility after colorectal surgery. Trial Registration JJ22011-15.


1997 ◽  
Vol 87 (1) ◽  
pp. 135-143 ◽  
Author(s):  
Joy L. Hawkins ◽  
Charles P. Gibbs ◽  
Miriam Orleans ◽  
Gallice Martin-Salvaj ◽  
Brenda Beaty

Background In 1981, with support from the American Society of Anesthesiologists and the American College of Obstetricians and Gynecologists, anesthesia and obstetric providers were surveyed to identify the personnel and methods used to provide obstetric anesthesia in the United States. The survey was expanded and repeated in 1992 with support from the same organizations. Methods Comments and questions from the American Society of Anesthesiologists Committee on Obstetrical Anesthesia and the American College of Obstetricians and Gynecologists Committee on Obstetric Practice were added to the original survey instrument to include newer issues while allowing comparison with data from 1981. Using the American Hospital Association registry of hospitals, hospitals were differentiated by number of births per year (stratum I, &gt; or = 1,500 births; stratum II, 500-1,499 births; stratum III, &lt; 500 births) and by U.S. census region. A stratified random sample of hospitals was selected. Two copies of the survey were sent to the administrator of each hospital, one for the chief of obstetrics and one for the chief of anesthesiology. Results Compared with 1981 data, there was an overall reduction in the number of hospitals providing obstetric care (from 4,163 to 3,545), with the decrease occurring in the smallest units (56% of stratum III hospitals in 1981 compared with 45% in 1992). More women received some type of labor analgesia and there was a 100% increase in the use of epidural analgesia. However, regional analgesia was unavailable in 20% of the smallest hospitals. Spinal analgesia for labor was used in 4% of parturients. In 1981, obstetricians provided 30% of epidural analgesia for labor; they provided only 2% in 1992. Regional anesthesia was used for 78-85% (depending on strata) of patients undergoing cesarean section, resulting in a marked decrease in the use of general anesthesia. Anesthesia for cesarean section was provided by nurse anesthetists without the medical direction of an anesthesiologist in only 4% of stratum I hospitals but in 59% of stratum III hospitals. Anesthesia personnel provided neonatal resuscitation in 10% of cesarean deliveries compared with 23% in 1981. Conclusions Compared with 1981, analgesia is more often used by parturients during labor, and general anesthesia is used less often in patients having cesarean section deliveries. In the smallest hospitals, regional analgesia for labor is still unavailable to many parturients, and more than one half of anesthetics for cesarean section are provided by nurse anesthetists without medical direction by an anesthesiologist. Obstetricians are less likely to personally provide epidural analgesia for their patients. Anesthesia personnel are less involved in newborn resuscitation.


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