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Preoperative Ketamine Has no Preemptive Analgesic Effect in Patients Undergoing Colon Surgery.

NCT02241278 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-09-16

No results posted yet for this study

Summary

The analgesic properties of ketamine are associated with its non-competitive antagonism of the N-methyl-D-aspartate receptor; these receptors exhibit an excitatory function on pain transmission and this binding seems to inhibit or reverse the central sensitization of pain. In the literature, the value of this anesthetic for preemptive analgesia in the control of postoperative pain is uncertain. The objective of this study was to ascertain whether preoperative low-dose ketamine reduces postoperative pain and morphine consumption in adults undergoing colon surgery.

In a double-blind, randomized trial, 48 patients were studied. Patients in the ketamine group received 0.5 mg/kg intravenous ketamine before surgical incision, while the control group received normal saline. The postoperative analgesia was achieved with a continuous infusion of morphine at 0.015 mg∙kgˉ¹∙hˉ¹ with the possibility of 0.02 mg/kg bolus every 10 min. Pain was assessed using the Visual Analog Scale (VAS), morphine consumption, and hemodynamic parameters at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively. We quantified times to rescue analgesic (Paracetamol), adverse effects and patient satisfaction.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Ketamine

In the operating room, the anesthesiologist administered 0.5 mg/kg of ketamine chlorhydrate in 50 mL of 0.9 % saline intravenously to patients in the ketamine group 30 minutes before surgical incision (a single dose).

Sponsors & Collaborators

  • Complexo Hospitalario Universitario de A Coruña

    collaborator OTHER

  • Hospital Arquitecto Marcide

    lead OTHER

Principal Investigators

  • Manuel Camba Rodriguez, M.D. · Hospital Arquitecto Marcide

  • Beatriz Nistal Nuno, M.D. · Complexo Hospitalario Universitario A Coruna

  • Enrique Freire-Vila, M.D. · Complexo Hospitalario Universitario A Coruna

  • Francisco Castro Seoane, M.D. · Hospital Arquitecto Marcide

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2002-06-30
Completion
2002-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02241278 on ClinicalTrials.gov