Three different doses of ketamine during general anaesthesia in caesarean section: A double blind, placebo controlled, randomized clinical trial

Bilgen, Semih; Köner, Özge; Türe, Hatice; Menda, Ferdi; Fıçıcıoğlu, Cem; Aykaç, Bora

doi:10.1097/00003643-201106001-00507

Cited by 8 publications

(41 citation statements)

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“…Тем не менее в обзоре M. Heesen и соавт. наблюдается гетерогенность в отношении доз кетамина, в частности, в трех РКИ [32,43,44] фигурируют дозы кетамина 1 мг/кг, что выходит за пределы субанестетического диапазона, а в одном из РКИ используется изомер кетамина S-кетамин [45]. В свете вышеизложенного мы посчитали необходимым проведение собственного систематического обзора с более жесткими критериями включения и изучением всего спектра благоприятных эффектов кетамина.…”

Section: Discussionunclassified

“…В двух исследованиях [9,40] влияние на послеоперационное обезболивание было изучено в качестве вторичного исхода. В четырех исследованиях [30,[32][33][34] пациенткам выполнялось кесарево сечение в условиях ОА, в остальных -в условиях СА. Самое раннее из четырех РКИ было выполнено в 2002 г.…”

Section: Discussionunclassified

“…В 2012 г. S. Bilgen и соавт. использовали три различные дозы кетамина 0,25 мг/кг, 0,5 мг/кг и 1,0 мг/кг [32]. Авторами не было обнаружено достоверных различий боли в баллах цифровой рейтинговой шкалы боли (ЦРШ) и суммарном потреблении морфина в течение первых 48 часов после операции, а также различий в отношении формирования хронической боли, регистрируемой на протяжении года после родоразрешения.…”

Section: Discussionunclassified

“…В двух исследованиях кетамин вводился и болюсно, и в виде продленной инфузии [30,31]. В двух исследованиях сравнивались клинические эффекты двух разных доз кетамина 0,25 мг/кг и 0,5 мг/кг [3,32]. В одном исследовании пациенткам основной группы кетамин вводился перед операцией в дозе 0,15 мг/кг [9].…”

Section: описания рки включенные в анализunclassified

“…В РКИ S. Bilgen и соавт. [32] нами была исключена из рассмотрения группа пациенток, получавших кетамин в дозе 1 мг/кг. В пяти из приведенных исследований [30,[32][33][34][35]] операция кесарева сечения проводилась в условиях общей анестезии (ОА), в остальных [3, 4, 7-9, 28, 29, 31, 36-40] -в условиях спинальной анестезии (СА).…”

Section: описания рки включенные в анализunclassified

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Clinical effects of low-dose intravenous ketamine in obstetrics: a systematic review

Shindyapina

Marshalov

Shifman³

et al. 2020

Annals of Critical Care

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Introduction. Over the past decade, there has been increased attention to ketamine, which is associated with the identification of its new effects when using low (less than 1 mg/kg for bolus administration and less than 20 μg/kg/min for prolonged infusion) doses of the drug. In pregnant women, the pharmacokinetics of most drugs change, so the results of studies of low doses of ketamine obtained in other categories of patients may not be reproduced in the obstetric population. Objectives. Assessment of the clinical effects of various doses and regimens of ketamine administration, within the subanesthetic range, in the perioperative period of cesarean section. Material and Methods. Publications were searched in the electronic databases PubMed, MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) by four reviewers independently. The date of the last search query was December 31, 2019. Results. A total of 18 randomized controlled trials (RCTs) involving 2703 patients were included in the review. The results of this systematic review showed that the administration of low doses of ketamine (in the range of 0.15-0.5 mg/kg) in the perioperative period of cesarean section performed under spinal anesthesia can reduce the intensity of pain and the need for analgesics in the postoperative period. The use of low doses of ketamine under these conditions can also be useful to reduce the severity of chills, itching, and the prevention of postoperative nausea and vomiting, post-puncture headache, and postpartum depression. Doses of less than 0.5 mg/kg appear to be safer and comparatively effective in the prevention of the above complications. However, the small number and high heterogeneity of research does not allow us to draw unambiguous conclusions. The effectiveness of low doses of ketamine in the prevention of these complications with general anesthesia also remains unclear. Conclusion. Further research and a meta-analysis of the data are necessary to obtain final conclusions.

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Section: Discussionunclassified

Section: описания рки включенные в анализunclassified

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Clinical effects of low-dose intravenous ketamine in obstetrics: a systematic review

Shindyapina

Marshalov

Shifman³

et al. 2020

Annals of Critical Care

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Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery

Wang

Deng

et al. 2023

JAMA Netw Open

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ImportanceEpidural anesthesia is a primary choice for cesarean delivery, but supplemental analgesics are often required to relieve pain during uterine traction.ObjectiveTo investigate the sedative and analgesic effects of intravenous esketamine administered before childbirth via cesarean delivery with the patient under epidural anesthesia.Design, Setting, and ParticipantsThis multicenter, double-blind randomized clinical trial assessed 903 women 18 years or older who had full-term single pregnancy and were scheduled for elective cesarean delivery with epidural anesthesia in 5 medical centers in China from September 18, 2021, to September 20, 2022.InterventionPatients were randomized to receive intravenous injection of 0.25 mg/kg of esketamine or placebo before incision.Main Outcomes and MeasuresThe coprimary outcomes included scores on the numeric rating scale of pain (an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain; a difference of ≥1.65 points was clinically meaningful) and Ramsay Sedation Scale (a 6-point scale, with 1 indicating restlessness and 6 indicating deep sleep without response; a difference of ≥2 points was clinically meaningful) immediately after fetal delivery. Secondary outcomes included neonatal Apgar score assessed at 1 and 5 minutes after birth.ResultsA total of 600 women (mean [SD] age, 30.7 [4.3] years) were enrolled and randomized; all were included in the intention-to-treat analysis. Immediately after fetal delivery, the score on the numeric rating scale of pain was lower with esketamine (median [IQR], 0 [0-1]) than with placebo (median [IQR], 0 [0-2]; median difference, 0; 95% CI, 0-0; P = .001), but the difference was not clinically important. The Ramsay Sedation Scale scores were higher (sedation deeper) with esketamine (median [IQR], 4 [3-4]) than with placebo (median [IQR], 2 [2-2]; median difference, 2; 95% CI, 2-2; P &lt; .001). The neonatal Apgar scores did not differ between the 2 groups at 1 minute (median difference, 0; 95% CI, 0-0; P = .98) and at 5 minutes (median difference, 0; 95% CI, 0-0; P = .27). Transient neurologic or mental symptoms were more common in patients given esketamine (97.7% [293 of 300]) than in those given placebo (4.7% [14 of 300]; P &lt; .001).Conclusions and RelevanceFor women undergoing cesarean delivery under epidural anesthesia, a subanesthetic dose of esketamine administered before incision produced transient analgesia and sedation but did not induce significant neonatal depression. Mental symptoms and nystagmus were common but transient. Indications and the optimal dose of esketamine in this patient population need further clarification, but study should be limited to those who require supplemental analgesia.Trial RegistrationClinicalTrials.gov Identifier: NCT04548973

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Perioperative Adjunctive Esketamine for Postpartum Depression Among Women Undergoing Elective Cesarean Delivery

Chen,

Guo,

et al. 2024

JAMA Netw Open

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ImportancePostpartum depression (PPD) is one of the most common mental health conditions during the perinatal and postpartum periods, which can have adverse effects on both mother and infant.ObjectiveTo investigate the efficacy of perioperative adjunctive esketamine administration after cesarean deliveries in the prevention of PPD.Design, Setting, and ParticipantsA single-center, double-blind, placebo-controlled, randomized clinical trial was conducted from January 1, 2022, to January 1, 2023, at Fujian Provincial Hospital among 298 women aged 18 to 40 years, with an American Society of Anesthesiologists grade I to III classification and singleton full-term pregnancies who were scheduled for elective cesarean deliveries. Primary analyses were performed on a modified intention-to-treat basis.InterventionsPatients were randomly assigned to the esketamine (n = 148) and control (n = 150) groups. Those in the esketamine group received a single intravenous injection of 0.25 mg/kg of esketamine immediately after fetal delivery, followed by 50 mg of esketamine as an adjuvant in patient-controlled intravenous analgesia for 48 hours after surgery. Saline was given to the control group of patients.Main Outcomes and MeasuresThe primary outcome was assessments of PPD symptoms by using the Edinburgh Postnatal Depression Scale (EPDS) at postpartum day 7. Positive screening for PPD was defined as a score of 10 or more points on the EPDS. In addition, the EPDS was analyzed as a continuous variable to evaluate depressive symptoms. Secondary outcomes included the Numeric Rating Scale (NRS) of postoperative pain, along with safety evaluations including adverse events and clinical assessments at postpartum days 14, 28, and 42.ResultsA total of 298 pregnant women were included, with 150 in the control group (median age, 31.0 years [IQR, 29.0-34.0 years]) and 148 in the esketamine group (median age, 31.0 years [IQR, 28.0-34.0 years]). The prevalence of depression symptoms was significantly lower among patients given esketamine compared with controls (23.0% [34 of 148] vs 35.3% [53 of 150]; odds ratio, 0.55; 95% CI, 0.33-0.91; P = .02) on postpartum day 7. In addition, the esketamine group also showed a significantly lower change in EPDS scores (difference of least-squares means [SE], −1.17 [0.44]; 95% CI, −2.04 to −0.31; effect size, 0.74; P = .008). However, there were no differences between the groups in the incidence of positive screening results for PPD or in changes from the baseline EPDS scores at postpartum days 14, 28, and 42. There were no differences in NRS scores at rest and on movement except on movement at 72 hours postoperatively, when scores were significantly lower in the esketamine group (median, 3.0 [IQR, 2.0-3.0] vs 3.0 [IQR, 3.0-3.5]; median difference, 0 [95% CI, 0-0]; P = .03).Conclusions and RelevanceThese results suggest that intravenous administration of esketamine during the perioperative period of elective cesarean delivery can improve depression symptoms during the early postpartum period. However, this antidepression effect may not be universally applicable to patients with low EPDS scores.Trial RegistrationChinese Clinical Trial Registry Identifier: ChiCTR2100054199

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Three different doses of ketamine during general anaesthesia in caesarean section: A double blind, placebo controlled, randomized clinical trial

Cited by 8 publications

References 1 publication

Clinical effects of low-dose intravenous ketamine in obstetrics: a systematic review

Clinical effects of low-dose intravenous ketamine in obstetrics: a systematic review

Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery

Perioperative Adjunctive Esketamine for Postpartum Depression Among Women Undergoing Elective Cesarean Delivery

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