Evaluation of the Effect of Ketamine on Hyperalgesia and IL-6 in Patients Underwent Laparoscopic Cholecystectomy With Remifentanil

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Plínio da Cunha Leal, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01301079
First received: February 22, 2011
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to determine whether ketamine is effective in preventing hyperalgesia that use of remifentanil can cause.


Condition Intervention Phase
Pain
Inflammatory Response
Drug: Ketamine
Drug: Saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Effect of Ketamine on Hyperalgesia and IL-6 in Patients Underwent Laparoscopic Cholecystectomy With Remifentanil

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain will be evaluated on postoperative through morphine consumption by patient controlled analgesia, by the pain threshold using monofilaments and pressure algometer around cicatrix surgery.

  • Inflammatory response [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Inflammatory response will be observed through the measurement of interleukin - 6 and CRP in the postoperative.


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketamine

The monitoring will be with cardioscopy, capnography, pulse oximetry, noninvasive blood pressure, urine output and thermometer. As premedication is administered 3 mg of midazolam 30 minutes before surgery.

Anesthesia is induced with propofol 2-4 mg/kg followed by atracurium 0.5 mg/kg to facilitate tracheal intubation. Two minutes after the injection of propofol is initiated dose of 1 mcg/kg remifentanil over 5 minutes. Atracurium doses are titrated to maintain muscle relaxation. After intubation, patients will be ventilated to normocapnia with 50% oxygen and without nitrous oxide.

Patients in group ketamine will receive remifentanil (0.4 mcg / kg / min) and ketamine (5mcg/kg/min).

Drug: Ketamine
Patients in group ketamine will receive ketamine (5mcg/kg/min) during the surgery.
Placebo Comparator: N

The monitoring will be with cardioscopy, capnography, pulse oximetry, noninvasive blood pressure, urine output and thermometer. As premedication is administered 3 mg of midazolam 30 minutes before surgery.

Anesthesia is induced with propofol 2-4 mg/kg followed by atracurium 0.5 mg/kg to facilitate tracheal intubation. Two minutes after the injection of propofol is initiated dose of 1 mcg/kg remifentanil over 5 minutes. Atracurium doses are titrated to maintain muscle relaxation. After intubation, patients will be ventilated to normocapnia with 50% oxygen and without nitrous oxide.

Patients in group N will receive remifentanil (0.4 mcg / kg / min) and saline (5mcg/kg/min).

Drug: Saline
Patients in group N (placebo)will receive saline during surgery.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 40 patients > 18 years old
  • both sexes
  • ASA I or II
  • undergoing laparoscopic cholecystectomy

Exclusion Criteria:

  • patients with chronic pain
  • myocardial ischemia
  • psychiatric illness
  • drug user
  • those who received opioids in the previous week
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301079

Contacts
Contact: Plínio da Cunha Leal, Anesthesiologist 55 (11) 6273-9646 pliniocunhaleal@hotmail.com

Locations
Brazil
Federal University of São Paulo Recruiting
São Paulo, Brazil
Contact: Plínio da Cunha Leal, Anesthesiologist       pliniocunhaleal@hotmail.com   
Contact: Rioko Kimiko Sakata       riokoks.dcir@epm.br   
Principal Investigator: Plínio da Cunha Leal, Anesthesiologist         
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Plínio da Cunha Leal, Anesthesiologist Federal University of São Paulo
  More Information

Publications:
Responsible Party: Plínio da Cunha Leal, Graduate Student, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01301079     History of Changes
Other Study ID Numbers: anaana
Study First Received: February 22, 2011
Last Updated: September 27, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Pain
Inflammatory response
Hyperalgesia
NMDA receptor

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketamine
Remifentanil
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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
Analgesics, Opioid
Narcotics
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on September 18, 2014