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

NCT02241278 | Completed Phase 4

• 1 other identifier: MK334037
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

colon surgery; ketamine; patient-controlled-analgesia; preemptive analgesia

Outcome Measures

Primary Outcomes (8)

• Visual Analog Scale (VAS) score

  The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

  at 0 hours postoperatively (arrival at recovery room)

• Visual Analog Scale (VAS) score

  The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

  at 1 hour postoperatively

• Visual Analog Scale (VAS) score

  The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

  at 2 hours postoperatively

• Visual Analog Scale (VAS) score

  The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

  at 4 hours postoperatively

• Visual Analog Scale (VAS) score

  The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

  at 8 hours postoperatively

• Visual Analog Scale (VAS) score

  The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

  at 12 hours postoperatively

• Visual Analog Scale (VAS) score

  The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

  at 16 hours postoperatively

• Visual Analog Scale (VAS) score

  The VAS represents a scale with the lowest value as 0 (no pain) and the highest value as 10 (worst imaginable pain).

  at 24 hours postoperatively

Secondary Outcomes (1)

• morphine consumption

  at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively

Other Outcomes (8)

• Blood Pressure (BP) systolic

  at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively

• Blood Pressure (BP) diastolic

  at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively

• Heart rate

  at 0, 1, 2, 4, 8, 12, 16, and 24 hours postoperatively.

Study Arms (2)

Control

PLACEBO COMPARATOR

In the operating room, the anesthesiologist administered 50 mL of 0.9% saline intravenously to patients in the control group 30 minutes before surgical incision.

Ketamine

EXPERIMENTAL

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).

Drug: Ketamine

Interventions

Ketamine DRUG

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).

Also known as: ketamine chlorhydrate

Ketamine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 75 years
• normal Body Mass Index (18.5 - 24.9)
• American Society of Anesthesiologists (ASA) class I, II or III
• elective surgery
• surgery time between 60-150 min
• understanding of the Visual Analog Scale (VAS)
• lack of allergies or intolerance to anesthetics
• absence of psychiatric illness

You may not qualify if:

• cognitive deterioration
• inability to use the Patient-Controlled-Analgesia (PCA) device
• history of chronic pain syndromes
• chronic use of analgesics, sedatives, opioids or steroids
• liver or hematologic disease,
• history of drug or alcohol abuse
• intolerance to ketamine or Paracetamol.

Sponsors & Collaborators

• Hospital Arquitecto Marcide: lead
• Complexo Hospitalario Universitario de A Coruña: collaborator

Study Sites (1)

Hospital Arquitecto Marcide

Ferrol, A Coruna, 15405, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Manuel Camba Rodriguez, M.D.

  Hospital Arquitecto Marcide

  STUDY CHAIR

• Beatriz Nistal Nuno, M.D.

  Complexo Hospitalario Universitario A Coruna

  PRINCIPAL INVESTIGATOR

• Enrique Freire-Vila, M.D.

  Complexo Hospitalario Universitario A Coruna

  STUDY DIRECTOR

• Francisco Castro Seoane, M.D.

  Hospital Arquitecto Marcide

  PRINCIPAL INVESTIGATOR

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: M.D.

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 16, 2014
• Study Start: September 1, 2001
• Primary Completion: June 1, 2002
• Study Completion: June 1, 2002
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

ES (1)