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Low Doses of Ketamine and Postoperative Quality of Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02571153
Recruitment Status : Completed
First Posted : October 8, 2015
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Eduardo Toshiyuki Moro, Pontificia Universidade Catolica de Sao Paulo

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).

Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Nausea and Vomiting Drug: Ketamine 0.4 mg/kg Drug: Normal saline Drug: Ketamine 0.2 mg/kg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Low Doses of Ketamine on Postoperative Quality of Recovery After Total Intravenous Anesthesia
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Placebo Comparator: Saline group
Normal saline 0.9% (5 mL)
Drug: Normal saline
Intravenous normal saline 0.9% 5 mL

Experimental: Ketamine 0.2
ketamine 0.2 mg/kg (5 mL)
Drug: Ketamine 0.2 mg/kg
Intravenous ketamine 0.2 mg/kg after induction of anesthesia

Experimental: Ketamine 0.4
ketamine 0.4 mg/kg (5 mL)
Drug: Ketamine 0.4 mg/kg
Intravenous ketamine 0.4 mg/kg after induction of anesthesia




Primary Outcome Measures :
  1. Quality of Postoperative Recovery Assessed by QoR-40 Questionnaire 24 Hours After Surgery [ Time Frame: 24 hours ]
    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.


Secondary Outcome Measures :
  1. Length of PACU Stay [ Time Frame: During the stay at postanesthesia recovery room (about 90 to 120 minutes) ]
    Length of stay at postanesthesia recovery room

  2. Occurrence of Postoperative, Nausea and Vomiting [ Time Frame: 24 hours ]
    Percentage of participants with postoperative nausea and vomiting at the PACU and during the hospital ward stay

  3. Occurrence of Pain at PACU Using a 0-10 Numeric Pain Rating Scale [ Time Frame: 90 minutes postanesthesia at recovery room ]
    Occurrence of pain at the PACU. Average Pain will be calculated. The pain score will be evaluated using a 0-10 numeric pain rating scale, where zero mean no pain and 10 the worst imaginable pain.

  4. Morphine Consumption (mg) at PACU [ Time Frame: During the stay at postanesthesia recovery room (about 90 to 120 minutes) ]
    Morphine consumption (mg) at PACU (about 90 to 120 minutes)

  5. The Severity of Postoperative Pain [ Time Frame: 24 hours ]

    The severity of postoperative pain was rated the higher score of pain (NRS) during the hospital ward stay.

    Pain was evaluated using a 0-10 numeric pain rating scale (NRS), where zero meant no pain and 10 the worst imaginable pain.


  6. Percentage of Participants With Tramadol Consumption [ Time Frame: 24 hours ]
    Percentage of Participants with Tramadol during the ward stay



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571153


Locations
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Brazil
Santa Lucinda Hospital
Sorocaba, SP, Brazil, 18030-230
Sponsors and Collaborators
Pontificia Universidade Catolica de Sao Paulo
Investigators
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Principal Investigator: Eduardo T Moro, PhD School of Medical and Health Sciences, Pontificial Catholic University of São Paulo - PUCSP
Publications:
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Responsible Party: Eduardo Toshiyuki Moro, Assistant Professor, Pontificia Universidade Catolica de Sao Paulo
ClinicalTrials.gov Identifier: NCT02571153    
Other Study ID Numbers: PUCSP 057539/2015
First Posted: October 8, 2015    Key Record Dates
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017
Last Verified: January 2017
Keywords provided by Eduardo Toshiyuki Moro, Pontificia Universidade Catolica de Sao Paulo:
Intravenous anesthesia
Postoperative nausea vomiting
Postoperative pain
Patient satisfaction
Quality of health care
Ketamine
Additional relevant MeSH terms:
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Pain, Postoperative
Nausea
Vomiting
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms, Digestive
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action