Lidocaine and Ketamine in Abdominal Surgery
|ClinicalTrials.gov Identifier: NCT00721110|
Recruitment Status : Terminated (Futility)
First Posted : July 23, 2008
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Hysterectomy (& Wertheim)||Drug: Lidocaine Drug: Placebo Drug: Ketamine Drug: Ketamine + Lidocaine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Perioperative Lidocaine and Ketamine Infusions on Acute Functional Recovery After Abdominal Hysterectomy|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||July 2012|
Active Comparator: Lidocaine
Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
Placebo Comparator: Placebo
A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
Placebo boluses and infusions will be substituted
Active Comparator: Ketamine
Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
Active Comparator: ketamine + Lidocaine
both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery.
Drug: Ketamine + Lidocaine
both Ketamine and Lidocaine will be given
- The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two [ Time Frame: postoperative day 2 ]The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.
- Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 [ Time Frame: PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2 ]Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain.
- Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 [ Time Frame: intraoperative through postoperative day 2 ]
- Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day [ Time Frame: 2 hours after surgery, on postoperative day 1 ]
- Verbal Response Fatigue Score on Postoperative Day 1 [ Time Frame: postoperative day 1 ]Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721110
|United States, Ohio|
|Cleveland Clinic/Hillcrest Hospital|
|Mayfield Heights, Ohio, United States, 44124|
|Principal Investigator:||Martin Grady, MD||Cleveland Clinic/Hillcrest Hospital|
|Study Chair:||Daniel I Sessler, MD||The Cleveland Clinic|