Phase 4
Completed N=135
Low Doses of Ketamine and Postoperative Quality of Recovery
Source: ClinicalTrials.gov NCT02571153 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Quality of Postoperative Recovery Assessed by QoR-40 Questionnaire 24 Hours After Surgery — 187.8; 189.6; 186.8 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Postoperative Recovery Assessed by QoR-40 Questionnaire 24 Hours After Surgery |
187.8; 189.6; 186.8 | — |
| SECONDARY Length of PACU Stay |
82.9; 84.5; 86 | — |
| SECONDARY Occurrence of Postoperative, Nausea and Vomiting |
30.8; 29.7; 39.5 | — |
| SECONDARY Occurrence of Pain at PACU Using a 0-10 Numeric Pain Rating Scale |
3.8; 2.6; 2.8 | — |
| SECONDARY Morphine Consumption (mg) at PACU |
1.6; 0.9; 1.1 | — |
| SECONDARY The Severity of Postoperative Pain |
3.2; 2.8; 3.6 | — |
| SECONDARY Percentage of Participants With Tramadol Consumption |
5.1; 10.8; 13.9 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02571153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.