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OpenTrials
Completed

NCT Number: NCT02421913

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Médico Campinas

Campinas, São Paulo, 13083190, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S(+)-Ketamine

Drug

S(+)-Ketamine 0,3mg/kg/hr intraoperative

Primary outcomes

  1. Morphine consumption

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Centro Medico Campinas

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 21, 2015
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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