scholarly journals Optimum dose of spinal ropivacaine with or without single intravenous bolus of S-ketamine during elective cesarean delivery: a randomized, double-blind, sequential dose-finding study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xiaoyu Zhang ◽  
Jianwei Wang ◽  
Xiao-Hu An ◽  
Yu-Chieh Chao ◽  
Yong Bian ◽  
...  
Keyword(s):  
Caesarean Delivery ◽  
Depression Scale ◽  
Dose Finding ◽  
High Rate ◽  
Optimum Dose ◽  
Sensory Level ◽  
Double Blind ◽  
Link Type ◽  
Vas Scores ◽  
Elective Caesarean Delivery

Abstract Background Maternal hypotension after spinal anaesthesia occurs at a high rate during caesarean delivery and can lead to adverse maternal or foetal outcomes. The aim of this study was to determine the optimal dose of spinal ropivacaine for caesarean section with or without intravenous single bolus of S-ketamine and to observe the rates of hypotension associated with both methods. Methods Eighty women undergoing elective caesarean delivery were randomly allocated into either a ropivacaine only or ropivacaine with intravenous S-ketamine group. If the upper sensory level of the patient reached T6 and the visual analogue scale (VAS) scores remained below 3 points before delivery, the next patient had a 1/9th chance of receiving a lower dose or an 8/9th chance of receiving the same dose as the previous patient. If the patient had VAS scores of more than 2 points or needed an extra epidural rescue bolus before delivery, a higher dose was used for the next patient. The primary outcome was the successful use of spinal ropivacaine to maintain patient VAS score of < 3 points before delivery and the incidence of post-spinal hypotension in both groups. Secondary outcomes included the rates of hypotension-related symptoms and interventions, upper sensory level of anaesthesia, level of sedation, neonatal outcomes, Edinburgh Postnatal Depression Scale scores at admission and discharge, and post-operative analgesic effect. The 90% effective dose (ED90) and 95% confidence interval (95% CI) were estimated by isotonic regression. Results The estimated ED90 of ropivacaine was 11.8 mg (95% CI: 11.7–12.7) with and 14.7 mg (95% CI: 14.6–16.0) without intravenous S-ketamine, using biased coin up-down sequential dose-finding method. The rates of hypotension and associated symptoms were significantly lower in S-ketamine group than in the ropivacaine only group. Conclusions A spinal dose of ropivacaine 12 mg with a single intravenous 0.15 mg/kg bolus dose of S-ketamine may significantly reduce the risk of hypotension and induce sedation before delivery. This method may be used with appropriate caution for women undergoing elective caesarean delivery and at a high risk of hypotension or experiencing extreme nervousness. Trial registration http://www.chictr.org.cn (ChiCTR2000040375; 28/11/2020).

scholarly journals Optimum Dose of Spinal Ropivacaine with or Without Single Intravenous Bolus of S-Ketamine During Elective Cesarean Delivery: A Randomized, Sequential Dose-Finding Study

2021 ◽  
Author(s):  
Xiaoyu Zhang ◽  
Jianwei Wang ◽  
Xiao-Hu An ◽  
Yu-Chieh Chao ◽  
Yong Bian ◽  
...  
Keyword(s):  
Cesarean Delivery ◽  
Depression Scale ◽  
Dose Finding ◽  
Optimum Dose ◽  
Sensory Level ◽  
Elective Cesarean Delivery ◽  
Clinical Trial Registration ◽  
Elective Cesarean ◽  
Vas Scores ◽  
Spinal Hypotension

Abstract Background Post-spinal hypotension has a high occurrence during cesarean delivery, and can lead to adverse maternal or fetal outcomes. The purpose of the study was to determine the optimal dose of spinal ropivacaine for cesarean section with or without intravenous single bolus of S-ketamine and to observe the incidences of hypotension of both methods. Methods Eighty women undergoing elective cesarean delivery were randomly allocated into Group ropivacaine or Group ropivacaine with intravenous S-ketamine. If the upper sensory level of the patient reached T6 and the visual analogue scale (VAS) scores continuously below 3 before delivery, the next patient had a 1/9th chance of receiving a lower dose or an 8/9th chance of receiving the same of previous dose. If the patient had VAS scores above 2 or needed an extra epidural rescue bolus before delivery, a higher dose was used for the next patient. The primary outcome was the successful use of spinal ropivacaine to maintain VAS of patients below 3 before delivery and the incidence of post-spinal hypotension of both groups. Secondary outcomes included the incidences of hypotension related symptoms and managements, upper sensory level of anesthesia, level of sedation, neonatal outcomes, Edinburgh postnatal depression scale scores on admission and discharging of hospital and post-operative analgesic effect. The 90% effective dose (ED90) and 95% confidence interval (95% CI) were estimated by isotonic regression. Results The estimated ED90 of ropivacaine was 11.8 mg (95% CI 11.7–12.7) with and 14.7 mg (95% CI 14.6–16.0) without intravenous S-ketamine using biased coin up-down sequential dose-finding method, and the incidences of hypotension and its related symptoms were significantly lower in S-ketamine group. Conclusions A spinal dose of ropivacaine 12 mg with single intravenous 0.15 mg/kg bolus dose of S-ketamine may significantly reduce the risk of hypotension and provide sedative status before delivery, thus the method could be cautiously used in parturients with high risks of hypotension or extreme nervousness. Clinical trial registration: http://www.chictr.org.cn (ChiCTR2000040375; 28 Nov 2020)

scholarly journals The ED50 and ED95 of oxytocin infusion rate for maintaining uterine tone during elective caesarean delivery: a dose-finding study

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Xiao Wei Qian ◽  
Dan M. Drzymalski ◽  
Chang Cheng Lv ◽  
Fei He Guo ◽  
Lu Yang Wang ◽  
...  
Keyword(s):  
Side Effects ◽  
Effective Dose ◽  
Infusion Rate ◽  
Caesarean Delivery ◽  
Dose Finding ◽  
Bolus Administration ◽  
Estimated Blood Loss ◽  
Oxytocin Infusion ◽  
Elective Cesarean ◽  
Elective Caesarean Delivery

Abstract Background The 90% effective dose (ED90) of oxytocin infusion has been previously estimated to be 16.2 IU h− 1. However, bolus administration of oxytocin prior to the infusion may decrease the infusion dose required. The aim of this study was to estimate the ED95 for oxytocin infusion after a bolus at elective caesarean delivery (CD) in nonlaboring parturients. Methods We performed a randomized, triple blinded study in 150 healthy termparturients scheduled for elective CD under epidural anaesthesia. After delivery of the infant and i.v. administration of 1 IU oxytocin as a bolus, Participants were randomized to receive oxytocin infusion at a rate of 0, 1, 2, 3, 5, or 8 IU h− 1, to be given for a total of 1 h. Uterine tone assessed by the blinded obstetrician as either adequate or inadequate. Secondary outcomes included estimated blood loss (EBL), requirement for supplemental uterotonic agents, and development of side effects. Results The 95% effective dose (ED95) of oxytocin infusion was estimated to be 7.72 IU h− 1 (95% confidence interval 5.80–12.67 IU h− 1). With increasing oxytocin infusion rate, the proportion of parturients who needed rescue oxytocin bolus or secondary uterotonic agents decreased. No significant among-group differences in the EBL and oxytocin-related side effects were observed. Conclusions In parturients who receive a 1 IU bolus of oxytocin during elective cesarean delivery, an infusion rate of oxytocin at 7.72 IU h− 1 will produce adequate uterine tone in 95% of parturients. These results suggest that the total dose of oxytocin administered in the postpartum period can be decreased when administered as an infusion after oxytocin bolus.

Oxytocin at elective caesarean delivery: a dose‐finding study in women with obesity

Anaesthesia ◽  
2020 ◽  
Author(s):  
E. Peska ◽  
M. Balki ◽  
C. Maxwell ◽  
X. Y. Ye ◽  
K. Downey ◽  
...  
Keyword(s):  
Caesarean Delivery ◽  
Dose Finding ◽  
Finding Study ◽  
Dose Finding Study ◽  
Elective Caesarean Delivery

scholarly journals Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gernot Marx ◽  
Kai Zacharowski ◽  
Carole Ichai ◽  
Karim Asehnoune ◽  
Vladimír Černý ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Severe Sepsis ◽  
Plasma Volume ◽  
Volume Replacement ◽  
Efficacy And Safety ◽  
Volume Responsiveness ◽  
Double Blind ◽  
Link Type ◽  
Icu Discharge

Abstract Background Sepsis is associated with capillary leakage and vasodilatation and leads to hypotension and tissue hypoperfusion. Early plasma volume replacement is required to achieve haemodynamic stability (HDS) and maintain adequate tissue oxygenation. The right choice of fluids to be used for plasma volume replacement (colloid or crystalloid solutions) is still a matter of debate, and large trials investigating the use of colloid solutions containing gelatine are missing. This study aims to investigate the efficacy and safety of plasma volume replacement using either a combined gelatine-crystalloid regime (1:1 ratio) or a pure crystalloid regime. Methods This is a prospective, controlled, randomized, double-blind, international, multicentric phase IV study with two parallel groups that is planned to be conducted at European intensive care units (ICUs) in a population of patients with hypovolaemia in severe sepsis/septic shock. A total of 608 eligible patients will be randomly assigned to receive either a gelatine-crystalloid regime (Gelaspan® 4% and Sterofundin® ISO, B. Braun Melsungen AG, in a 1:1 ratio) or a pure crystalloid regime (Sterofundin® ISO) for plasma volume replacement. The primary outcome is defined as the time needed to achieve HDS. Plasma volume replacement will be target-controlled, i.e. fluids will only be administered to volume-responsive patients. Volume responsiveness will be assessed through passive leg raising or fluid challenges. The safety and efficacy of both regimens will be assessed daily for 28 days or until ICU discharge (whichever occurs first) as the secondary outcomes of this study. Follow-up visits/calls will be scheduled on day 28 and day 90. Discussion This study aims to generate evidence regarding which regimen—a gelatine-crystalloid regimen or a pure crystalloid regimen—is more effective in achieving HDS in critically ill patients with hypovolaemia. Study participants in both groups will benefit from the increased safety of target-controlled plasma volume replacement, which prevents fluid administration to already haemodynamically stable patients and reduces the risk of harmful fluid overload. Trial registration The European clinical trial database EudraCT 2015-000057-20 and the ClinicalTrials.gov Protocol Registration and Results System ClinicalTrials.gov NCT02715466. Registered on 17 March 2016.

scholarly journals Exenatide once weekly over 2 years as a potential disease-modifying treatment for Parkinson’s disease: protocol for a multicentre, randomised, double blind, parallel group, placebo controlled, phase 3 trial: The ‘Exenatide-PD3’ study

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047993
Author(s):  
Nirosen Vijiaratnam ◽  
Christine Girges ◽  
Grace Auld ◽  
Marisa Chau ◽  
Kate Maclagan ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Primary Outcome ◽  
Phase 3 ◽  
Double Blind ◽  
Treatment Groups ◽  
Link Type ◽  
South Central ◽  
Disease Modifying ◽  
Secondary Outcomes

IntroductionParkinson’s disease (PD) is a common neurodegenerative disorder with substantial morbidity. No disease-modifying treatments currently exist. The glucagon like peptide-1 receptor agonist exenatide has been associated in single-centre studies with reduced motor deterioration over 1 year. The aim of this multicentre UK trial is to confirm whether these previous positive results are maintained in a larger number of participants over 2 years and if effects accumulate with prolonged drug exposure.Methods and analysisThis is a phase 3, multicentre, double-blind, randomised, placebo-controlled trial of exenatide at a dose of 2 mg weekly in 200 participants with mild to moderate PD. Treatment duration is 96 weeks. Randomisation is 1:1, drug to placebo. Assessments are performed at baseline, week 12, 24, 36, 48, 60, 72, 84 and 96 weeks.The primary outcome is the comparison of Movement Disorders Society Unified Parkinson’s Disease Rating Scale part 3 motor subscore in the practically defined OFF medication state at 96 weeks between participants according to treatment allocation. Secondary outcomes will compare the change between groups among other motor, non-motor and cognitive scores. The primary outcome will be reported using descriptive statistics and comparisons between treatment groups using a mixed model, adjusting for baseline scores. Secondary outcomes will be summarised between treatment groups using summary statistics and appropriate statistical tests to assess for significant differences.Ethics and disseminationThis trial has been approved by the South Central-Berkshire Research Ethics Committee and the Health Research Authority. Results will be disseminated in peer-reviewed journals, presented at scientific meetings and to patients in lay-summary format.Trial registration numbersNCT04232969, ISRCTN14552789.

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