Low Doses of Ketamine and Postoperative Quality of Recovery

NCT02571153 | Completed Phase 4 Results

• 1 other identifier: PUCSP 057539/2015
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

There are evidences that intraoperative administration of low doses of ketamine may contribute to control the postoperative pain by acting on the N-methyl-D-aspartate (NMDA) channel, reducing the effects related to the tolerance and hyperalgesia induced by opioids. This study aims to evaluate the effects of administration of this agent not only as an analgesic but also its role in the quality of recovery from anesthesia, which includes observation of emotional, psychological and physical aspects. Patients who were scheduled to undergo total intravenous anesthesia (TIVA) for laparoscopic cholecystectomy will be enrolled in this clinical study. After induction of anesthesia, patients will receive one of three solutions according to the randomly selected group: ketamine 0,2 mg/kg; ketamine 0,4 mg/kg or saline. In the recovery room and on the ward, data related to the presence of pain, analgesic consumption, the incidence of nausea and vomiting, dizziness or hallucinations will be recorded. The next day, the quality of recovery will be evaluated by application of the questionnaire QoR40 (Quality of Recovery Questionnaire-40).

Conditions

Postoperative Pain; Postoperative Nausea and Vomiting

Keywords

Intravenous anesthesia; Postoperative nausea vomiting; Postoperative pain; Patient satisfaction; Quality of health care; Ketamine

Outcome Measures

Primary Outcomes (1)

• Quality of Postoperative Recovery Assessed by QoR-40 Questionnaire 24 Hours After Surgery

  Quality of postoperative functional recovery assessed by the questionnaire QoR40 The quality of postoperative functional recovery was assessed by the QoR-40 questionnaire, which assesses five dimensions of recovery (physical comfort - 12 items; emotional state - 7 items; physical independence - 5 items; physiological support - 7 items; and pain - 7 items). Each item was rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery). The QoR-40 was administered by a blind investigator 24 hours after surgery.

  24 hours

Secondary Outcomes (6)

• Length of PACU Stay

  During the stay at postanesthesia recovery room (about 90 to 120 minutes)

• Occurrence of Postoperative, Nausea and Vomiting

  24 hours

• Occurrence of Pain at PACU Using a 0-10 Numeric Pain Rating Scale

  90 minutes postanesthesia at recovery room

• Morphine Consumption (mg) at PACU

  During the stay at postanesthesia recovery room (about 90 to 120 minutes)

• The Severity of Postoperative Pain

  24 hours

Study Arms (3)

Saline group

PLACEBO COMPARATOR

Normal saline 0.9% (5 mL)

Drug: Normal saline

Ketamine 0.2

EXPERIMENTAL

ketamine 0.2 mg/kg (5 mL)

Drug: Ketamine 0.2 mg/kg

Ketamine 0.4

EXPERIMENTAL

ketamine 0.4 mg/kg (5 mL)

Drug: Ketamine 0.4 mg/kg

Interventions

Ketamine 0.4 mg/kg DRUG

Intravenous ketamine 0.4 mg/kg after induction of anesthesia

Ketamine 0.4

Normal saline DRUG

Intravenous normal saline 0.9% 5 mL

Saline group

Ketamine 0.2 mg/kg DRUG

Intravenous ketamine 0.2 mg/kg after induction of anesthesia

Ketamine 0.2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status I or II
• Patients scheduled to undergo laparoscopic cholecystectomy

You may not qualify if:

• Patients who refuse to participate in the study
• Patients who are not able to communicate due to alterations in the level of consciousness, or neurologic, or psychiatric disease
• Contraindication of any of the drugs used in the study
• Patients who are superobese (BMI\>40)
• History of alcohol or drug dependence

Sponsors & Collaborators

• Pontificia Universidade Catolica de Sao Paulo: lead

Study Sites (1)

Santa Lucinda Hospital

Sorocaba, São Paulo, 18030-230, Brazil

Location

Related Publications (5)

• Xie H, Wang X, Liu G, Wang G. Analgesic effects and pharmacokinetics of a low dose of ketamine preoperatively administered epidurally or intravenously. Clin J Pain. 2003 Sep-Oct;19(5):317-22. doi: 10.1097/00002508-200309000-00006.

  PMID: 12966258 BACKGROUND

• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

• Wu L, Huang X, Sun L. The efficacy of N-methyl-D-aspartate receptor antagonists on improving the postoperative pain intensity and satisfaction after remifentanil-based anesthesia in adults: a meta-analysis. J Clin Anesth. 2015 Jun;27(4):311-24. doi: 10.1016/j.jclinane.2015.03.020. Epub 2015 Mar 29.

  PMID: 25824051 BACKGROUND

• Pfenninger EG, Durieux ME, Himmelseher S. Cognitive impairment after small-dose ketamine isomers in comparison to equianalgesic racemic ketamine in human volunteers. Anesthesiology. 2002 Feb;96(2):357-66. doi: 10.1097/00000542-200202000-00022.

  PMID: 11818769 BACKGROUND

• Kissin I, Bright CA, Bradley EL Jr. The effect of ketamine on opioid-induced acute tolerance: can it explain reduction of opioid consumption with ketamine-opioid analgesic combinations? Anesth Analg. 2000 Dec;91(6):1483-8. doi: 10.1097/00000539-200012000-00035.

  PMID: 11094005 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Patient Satisfaction

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Eduardo Toshiyuki Moro
• Organization: Pontificia UCSP

eduardo_moro@terra.com.br

Study Officials

• Eduardo T Moro, PhD

  School of Medical and Health Sciences, Pontificial Catholic University of São Paulo - PUCSP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 8, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Locations

BR (1)