Ketamine Effect After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study

Ketamine

Brief Summary

Laparoscopic surgery for gastric reduction is frequently associated with high levels of postoperative pain. Postoperative pain is very often treated with opioids. However large doses of opioids can result in respiratory depression with hypoxemia especially in high risk patients with obstructive sleep apnea. since a large group of patients undergoing surgery for gastric reduction surgery also have obstructive sleep apnea, it is expected that these patients are also at high risk for postoperative respiratory depression and hypoxemia. Intraoperative ketamine has been used as an effective multimodal agent to reduce postoperative pain. However, ketamine alone has not been examined to improve postoperative pain outcomes in patients undergoing gastric reduction surgery. More importantly, it is unknown if the use of intraoperative ketamine can lead to better overall quality of recovery in the same patient population. In addition, ketamine has been shown to improve ventilation but it remains to be determined if the intraoperative use of ketamine will result in less postoperative hypoxemic events. The main objective of the current investigation is to examine the effect of intraoperative ketamine on postoperative quality of recovery after gastric reduction surgery. The investigators hypothesize that subjects receiving ketamine will have a greater global quality of recovery score than the ones receiving saline.

Intervention / Treatment

  • Ketamine (DRUG)
    Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).
  • Placebo (DRUG)
    Group P (placebo) will receive the same amount of saline.

Condition or Disease

  • Pain
  • Obesity
  • Hypoxia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 64 Years
    Enrollment: 80 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Nov 01, 2013 ACTUAL
    Primary Completion: Jul 26, 2019 ACTUAL
    Completion Date: Aug 22, 2019 ACTUAL
    Study First Posted: Nov 28, 2013 ESTIMATED
    Results First Posted: Oct 07, 2019 ACTUAL
    Last Updated: Oct 03, 2019

    Sponsors / Collaborators

    Lead Sponsor: Northwestern University
    Responsible Party: N/A

    Location

    Chicago, Illinois, USA

    Participant Groups

    • Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).

    • Group P (placebo) will receive the same amount of saline.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 64
    Age Groups: Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Age 18-64
    * surgery: laparoscopic gastric reduction (gastric sleeve or gastric bypass)
    * ASA physical status classification I, II, III
    * Body Mass Index \>35kg/m2
    * Fluent in English

    Exclusion Criteria:

    * History of allergy to protocol medications
    * History of chronic opioid use
    * Pregnant patients
    * Drop out: Conversion to an open surgical route, patient or surgeon request.

    Primary Outcomes

    • Scores on QOR (quality of recovery) 40 questionnaire. The QoR-40 score, which ranges from 40 to 200, representing very poor (low scores) to outstanding quality of recovery (high scores), respectively.

    Secondary Outcomes

    • Total number of opioids (morphine equivalents) consumed 24 hours after surgery

    • Participants pain scores will be recorded at 24 hours after surgery. Pain scores range from 0 (no pain) to 10 (worst pain imaginable).

    • The subjects length of hospital stay will be recorded. Length of stay is defined as day of surgery to date of discharge from the hospital which may be up to 2 weeks..

    More Details

    NCT Number: NCT01997515
    Other IDs: STU00081191
    Study URL: https://clinicaltrials.gov/study/NCT01997515
    Last updated: Sep 29, 2023