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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997515
• Other study ID #: STU00081191
• Status: Completed
• Phase: Phase 4
• Start date: November 2013
• Est. completion date: August 22, 2019

Study information

• Verified date: October 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 22, 2019
• Est. primary completion date: July 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoxia
• Obesity
• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Han PY, Duffull SB, Kirkpatrick CM, Green B. Dosing in obesity: a simple solution to a big problem. Clin Pharmacol Ther. 2007 Nov;82(5):505-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery 40	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.	24 hours
Secondary	Postoperative Opioid Consumption	Total number of opioids (morphine equivalents) consumed 24 hours after surgery	24 hours
Secondary	Postoperative Pain Scores	Participants pain scores will be recorded at 24 hours after surgery. Pain scores range from 0 (no pain) to 10 (worst pain imaginable).	24 hours
Secondary	Length of Hospital Stay	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..	Up to 2 weeks