Effect of Ketamine on Postoperative Clinical Outcomes

Phase 4

Terminated

• Conditions: Colorectal Surgery
• Interventions: Drug: Placebo; Drug: Ketamine high-dose; Drug: Ketamine low-dose

• Registration Number: NCT01365195
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

The purpose of this research is to evaluate the effectiveness of ketamine as an analgesic adjuvant in decreasing the narcotic (opioids) analgesics during surgery, on pain management and on the later recovery after surgery in patients undergoing colorectal surgery.

Detailed Description

Adjuvant is a drug that has few or no pharmacological effects by itself, but may increase the effectiveness or strength of other drugs when given at the same time.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-01
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2022-01-17
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Results First Posted: 2022-03-02
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Ketamine low-dose	Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate
Ketamine low-dose	Placebo	Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
Control	Ketamine high-dose	Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate
Ketamine high-dose	Ketamine low-dose	Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Ketamine high-dose	Placebo	Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
Ketamine low-dose	Ketamine high-dose	Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min

Primary Outcome Measures

Name	Time	Method
Number of Participants With Opioid Consumption	1 day	Perioperative use of opioid consumption at Post Anesthesia Care Unit (PACU) Data obtained from patient charts

Secondary Outcome Measures

Name	Time	Method
Participants With Nausea and Vomiting at PACU	1 day	Postoperative nausea and vomiting at PACU Participants experiencing nausea and/or vomiting.
Postoperative Pain	one day	Postoperative pain was measured at PACU using a Verbal Rating Scale (VRS) from 0 to 10 with 0 representing "no pain" and 10 "very much pain.

Trial Locations

Locations (1)

Cedars Sinai Medical center; 🇺🇸 Los Angeles, California, United States