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Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Perioperative depressive symptoms (PDS) are common mental comorbidities that influence clinical outcomes and prognosis. However, there is no rapid-acting treatment to address these symptoms during a limited hospital stay. METHODS/DESIGN:This is a single-center, randomized, placebo-controlled, and double-blind trial. Randomization will be applied and stratified by the severity of PDS (moderate versus severe). Eighty patients who are scheduled for elective supratentorial brain tumor resection with PDS will be randomly allocated to the ketamine or placebo group with a ratio of 1 to 1. Patients in the ketamine group will be administered low-dose ketamine (0.5 mg/kg) intravenously for 40 min while the dural mater is being cut into, whereas patients in the placebo group will receive the same volume of normal saline at the same infusion rate at the same time points. The primary endpoint is the rate of PDS response at 3 days after surgery. Secondary outcomes include efficacy parameters such as the rate of PDS remission and safety outcomes such as the incidence of postoperative delirium, quality of recovery, and psychiatric side effects. DISCUSSION:This study aims to determine whether ketamine could improve the depressive symptoms of perioperative patients undergoing supratentorial brain tumor resection. It will also examine the safety of administering ketamine as an intraoperative anti-depressant. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03086148 . Registered on 22 March 2017.

SUBMITTER: Zhou Y

PROVIDER: S-EPMC6114290 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial.

Zhou Yang Y Peng Yuming Y Fang Jinghan J Sun Wanchen W Zhang Guofu G Zhen Long L Wang Gang G Han Ruquan R

Trials 20180829 1

<h4>Background</h4>Perioperative depressive symptoms (PDS) are common mental comorbidities that influence clinical outcomes and prognosis. However, there is no rapid-acting treatment to address these symptoms during a limited hospital stay.<h4>Methods/design</h4>This is a single-center, randomized, placebo-controlled, and double-blind trial. Randomization will be applied and stratified by the severity of PDS (moderate versus severe). Eighty patients who are scheduled for elective supratentorial ...[more]

PMID: 30157913

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Project description:Background: Patients with Crohn's disease (CD) undergoing bowel resection often suffer from depression and acute pain, which severely impairs their recovery. We aimed to investigate the effects of S-ketamine preconditioning on postoperative depression in patients with CD undergoing a bowel resection with mild to moderate depression and to observe whether it can relieve postoperative pain and anti-inflammation. Methods: A total of 124 adult patients were randomized into one of the two groups. Patients in the S-ketamine group received a 0.25 mg/kg S-ketamine intravenous drip under general anesthesia induction, followed by a continuous infusion of S-ketamine with 0.12 mg/kg/h for more than 30 min through target-controlled infusion. Patients in the placebo group received 0.9% saline at an identical volume and rate. The primary outcome measure was the 17-item Hamilton depression Scale (HAMD-17). The secondary outcomes were scores on the following questionnaires: a nine-item patient health questionnaire (PHQ-9); a quality of recovery (QoR-15) form; and a numeric rating scale (NRS). Additional secondary outcomes included the levels of C-reactive protein (CRP) and interleukin 6 (IL-6) on postoperative days (PODs) 1, 3, and 5, the length of hospital stay, and opioid use throughout the hospital stay. Results: The scores of PHQ-9 and HAMD-17 in the S-ketamine group were lower than those in the placebo group on postoperative days (PODs) 1, 2, and 7 (p < 0.05). The scores of QoR-15 in the S-ketamine group were higher than those in the placebo group on postoperative days (PODs) 3 and 5 (p < 0.05). The NRS scores of PACU, postoperative days 1 and 2 in the S-ketamine group were lower than those in the placebo group (p < 0.05). There was no significant difference in the CRP and IL-6 levels on postoperative days (PODs) 1, 3, and 5, postoperative complications, and hospital stay between the two groups (p > 0.05). Conclusions: The trial indicated that the intraoperative administration of low-dose S-ketamine could alleviate mild-to-moderate depressive symptoms and postoperative pain in patients with Crohn's disease undergoing bowel resection without worsening their safety.

Project description:BackgroundKetamine is approved for antidepressant therapy, but evidence regarding its use in women with perinatal depression is lacking. Herein, we investigated the effects of low-dose ketamine in women with prenatal depressive symptoms and tested the feasibility of a future large randomized trial.MethodsThis was a randomized, double-blind, placebo-controlled pilot trial. Sixty-six women with prenatal depressive symptoms who were scheduled for elective cesarean delivery were randomized to receive either low-dose ketamine (0.5 mg/kg) or placebo (normal saline). The study drugs were intravenously infused over a 40-minute period after clamping the umbilical cord. The primary outcome was depression score assessed with the Edinburgh Postnatal Depression Scale at 48 h postpartum. Among other and safety outcomes, occurrence of nausea or vomiting was observed, pain intensity was assessed with the numeric rating scale. The feasibility of implementing the protocol was also evaluated.ResultsA total of 64 parturients were included in the intention-to-treat analysis. The depression score at 48 h did not differ between groups: median 9 (interquartile range 6 to 13) with ketamine vs. 8 (6 to 10) with placebo; median difference 1, 95% CI -1 to 3; P = 0.608. The pain intensity at 4 h postpartum was less severe in the ketamine group (median difference -1, 95% CI -1 to 0, P = 0.002). Among safety outcomes, intraoperative nausea or vomiting was less common in patients given ketamine (0.0% [0/33] with ketamine vs. 21.2% [7/33] with placebo, P = 0.011). Recruitment was satisfactory and the protocol was acceptable to participants and clinicians.ConclusionsA single low-dose ketamine infusion did not decrease the depression score at 2 days, but reduced intraoperative nausea and vomiting and lowered pain intensity at 4 h after cesarean delivery among women with prenatal depressive symptoms. The study protocol is feasible for a large randomized trial.Clinical trial registrationThe study was registered with ClinicalTrials.gov (identifier: NCT03336541; 08/11/2017).

Project description:IntroductionTechniques using local anaesthetics provide high-quality analgesia, while the anti-inflammatory properties of these drugs may represent an additional advantage. Perioperative intravenous lidocaine has shown positive effects not only on postoperative pain but also on bowel function and duration of hospital stay, due to its analgesic, anti-inflammatory and opioid-sparing effects. However, these potential benefits are not well established in patients undergoing resection with colorectal cancer. This research aims to determine the effect of perioperative intravenous lidocaine on postoperative outcomes in patients undergoing resection of colorectal cancer.Methods and analysisPubMed, Embase, Web of Science, CNKI, SinoMed and WanFang Data databases were electronically retrieved to include the randomised controlled trials comparing perioperative intravenous lidocaine with placebo infusion in patients undergoing resection of colorectal cancer before August 2021. Registers of clinical trials, potential grey literature and abstracts from conferences will also be searched. Two reviewers will screen literature, extract data and assess risk of bias of studies included independently. The primary outcome variable will be long-term survival outcome, tumour recurrence and metastasis rate, and restoration of intestinal function. The secondary outcome variables will consist of the severity of postoperative pain at 4, 12, 24 and 48 hours after surgery, the incidence of postoperative nausea and vomiting, and the length of hospital stay. A meta-analysis will be performed using RevMan V.5.4 software provided by the Cochrane Collaboration and Stata V.12.0. subgroup and sensitivity analyses will be conducted.Ethics and disseminationBecause the data used for this systematic review will be exclusively extracted from published studies, ethical approval and informed consent of patients will not be required. The systematic review will be published in a peer-reviewed journal, presented at conferences and shared on social media platforms.Prospero registration numberCRD42020216232.

Dataset Information

Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial.

Publications

Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial.

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