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NCT Number: NCT01997515

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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).

Other names: Ketalar

Placebo

Drug

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

Other names: Sterile .9 Normal Saline

Primary outcomes

  1. Quality of Recovery 40

    Time frame: 24 hours

    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

  1. Postoperative Opioid Consumption

    Time frame: 24 hours

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

  2. Postoperative Pain Scores

    Time frame: 24 hours

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

  3. Length of Hospital Stay

    Time frame: Up to 2 weeks

    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..

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Ketamine Effect on Recovery and Respiratory Outcomes After Laparoscopic Gastric Reduction: A Randomized, Double-Blinded, Placebo Controlled Study

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2013
Registry last updated
Oct 7, 2019

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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