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Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain

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ClinicalTrials.gov Identifier: NCT02421913
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
LUIZ EDUARDO DE PAULA GOMES MIZIARA, Centro Medico Campinas

Brief Summary:
Background: The use of low-dose continuous infusion of S(+)-ketamine combined with target-controlled intravenous anesthesia with remifentanil and propofol may be related to the control of postoperative pain and of opioid-induced hyperalgesia. The present study aimed to evaluate the efficacy of continuous infusion of S(+)-ketamine given intraoperatively in the control of postoperative pain compared to placebo.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: S(+)-Ketamine Phase 4

Detailed Description:
Methods: This is a double-blind randomized controlled trial with 48 patients of both genders aged from 18 to 65 years who underwent videolaparoscopic cholecystectomy. After venipuncture, patients received intravenous parecoxib sodium (40 mg). Target-controlled intravenous anesthesia was induced with propofol and remifentanil associated with rocuronium and adjusted to maintain the bispectral index between 35 and 50. The S(+)-ketamine group (SG) group received a continuous infusion of S(+)-ketamine at a dose of 0.3mg.kg-1.h-1, while the placebo group (PG) received a continuous infusion of saline at the same dose. Postoperative analgesia was measured by a verbal numerical scale (VNS) from 0 to 10 during 12 hours and treated with morphine when VNS score was equal to or higher than 3 at a dose of 0.05 mg.kg-1 when the patient reported pain for the first time and at a dose of 0.025mg.kg-1 on subsequent occasions. Pain scores were recorded in the postoperative care unit (PACU) and at 4 and 12 hours after the end of the surgery The amount of morphine used during PACU stay, from PACU discharge to 4 hours after surgery, and from 4 to 12 hours after surgery, the overall dose of morphine used, and possible adverse effects were also assessed

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of S(+)-Ketamine Administered as a Continuous Infusion for the Control of Postoperative Pain: a Randomized Controlled Trial
Study Start Date : June 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: S(+)-ketamine group (SG)
Five minutes before surgery, patients in the SG group received an intravenous continuous infusion containing 0.3 mg.kg-1.h-1 of S(+)-ketamine
Drug: S(+)-Ketamine
S(+)-Ketamine 0,3mg/kg/hr intraoperative

Placebo Comparator: placebo group (PG)
PG received the same dose of saline.



Primary Outcome Measures :
  1. Morphine consumption [ Time Frame: 12 hours ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 Years to 65 Years ASA I and II Accepts healthy volunteers.

Exclusion Criteria:

alcohol or illicit drugs, H2 inhibitors, opioids, or calcium-channel blockers within the last 10 days chronic pain, myocardial ischemia, psychiatric diseases.


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): NCT02421913


Locations
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Brazil
Centro Médico Campinas
Campinas, SP, Brazil, 13083190
Sponsors and Collaborators
Centro Medico Campinas

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LUIZ EDUARDO DE PAULA GOMES MIZIARA, Physician, Centro Medico Campinas
ClinicalTrials.gov Identifier: NCT02421913     History of Changes
Other Study ID Numbers: CMCampinas
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
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