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

NCT01997515 | Completed Phase 4 Results

• 1 other identifier: STU00081191
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Obesity; Hypoxia

Keywords

Quality of Recovery 40 Questionaire; Pain; Hypoxia; Gastric Surgery; Obesity; Ketamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative Opioid Consumption

  24 hours

• Postoperative Pain Scores

  24 hours

• Length of Hospital Stay

  Up to 2 weeks

Study Arms (2)

Group K (Ketamine)

ACTIVE COMPARATOR

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).

Drug: Ketamine

Group P (Placebo)

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

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).

Also known as: Ketalar

Group K (Ketamine)

placebo DRUG

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

Also known as: Sterile .9 Normal Saline

Group P (Placebo)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related 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. doi: 10.1038/sj.clpt.6100381.

  PMID: 17952107 BACKGROUND

MeSH Terms

Conditions

Pain; Obesity; Hypoxia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Director of Research
• Organization: Rhode Island Hospital

mark.kendall@lifesapn.org

401-444-4933

Study Officials

• Meltem Yilmaz, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 28, 2013
• Study Start: November 1, 2013
• Primary Completion: July 26, 2019
• Study Completion: August 22, 2019
• Last Updated: October 7, 2019
• Results First Posted: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)