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The Effect of Low Dose Ketamine on Narcotic Consumption in Patients Undergoing Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT05444777
Recruitment Status : Completed
First Posted : July 6, 2022
Last Update Posted : July 8, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Saima Rashid, Aga Khan University

Tracking Information
First Submitted Date  ICMJE March 17, 2021
First Posted Date  ICMJE July 6, 2022
Last Update Posted Date July 8, 2022
Actual Study Start Date  ICMJE January 17, 2013
Actual Primary Completion Date November 30, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2022)
pain score using Visual Analogue scale, ranging from 0 (minimum) and 10 (maximum), 3 and below showing no pain and scores above 3 showing moderate to severe pain. [ Time Frame: Baseline on arrival in the post anaesthesia care unit and then every fifteen minutes unto one hour ]
Change in pain score using Visual Analogue Scale
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2022)
pain score using Visual Analogue scale, ranging from 0 (minimum) and 10 (maximum), 3 and below showing no pain and scores above 3 showing moderate to severe pain. [ Time Frame: postoperatively for an hour in post anaesthesia care unit ]
Change in pain score using Visual Analogue Scale
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2022)
narcotic consumption in the post operative anaesthesia care unit [ Time Frame: postoperatively, after arrival in the post anaesthesia care unit at every fifteen minutes unto one hour ]
requirement of narcotic in the post anaesthesia care unit
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2022)
post operative narcotic consumption [ Time Frame: postoperatively for an hour in post anaesthesia care unit ]
Change in post operative narcotic consumption
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Low Dose Ketamine on Narcotic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
Official Title  ICMJE The Effect of Low Dose Ketamine on Narcotic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
Brief Summary The study was a double-blind randomized controlled trial, carried out at the Department of Anaesthesia, Aga Khan University Hospital. Sample size was calculated to be 86 with 80% power at 5% significance level assuming a 30% difference in the mean narcotic consumption in the test group using NCSS~Pass (version, 11.04)(Reference for calculation). Patients were divided into two groups of 43 each, one received saline and the other received 0.5mg/kg ketamine before wound closure. Randomization was done with the help of sealed envelope method. All patients were observed in the recovery room for one hour to see the magnitude of post-operative pain using Visual Analogue Scale. The amount of narcotic consumption was noted. Data were analyzed using SPSS version 19.
Detailed Description

Pain management is an essential component of every surgical procedure due to its effect on early mobilization. Adequate pain relief leads to rapid recovery and improved surgical outcome. It also decreases the chances of deep vein thrombosis, neuropathic pain and cardio-respiratory complications resulting in decreased cost and length of stay in the hospital. Poorly managed pain is not only inhuman but also detrimental for the patient's overall condition.

Several narcotic and non-narcotic modalities have been used to achieve for adequate post-operative analgesia. Among these, opioid narcotics are widely used due to their potent analgesic effect. Unfortunately opioids have a number of unwanted side-effects including respiratory depression, chest rigidity, drowsiness, nausea and vomiting. These unwanted side-effects had been shown to be decreased by the use of low-dose ketamine used immediately before wound closure in a number of surgeries. It has been reported that single dose of 0.15-1 mg/kg ketamine along with opioids was effective in decreasing the post-operative narcotic consumption. Availability of narcotics is also an issue worldwide particularly in low income countries. Alternate drugs and methods have been tried to minimize opioid use. Low dose ketamine seems to be an effective adjunct in reducing opioid requirement during perioperative period. Subcutaneous and spray of low dose ketamine has also been tried successfully for tonsillectomy pain. The role of low dose ketamine in patients undergoing laparoscopic cholecystectomy is not clear and is yet to be studied in our population. To analyze this effect a randomized controlled trial was performed to study the effect of low-dose ketamine on the narcotic consumption in PACU after laparoscopic cholecystectomy.

Materials and Methods:

The Double Blind Randomized Controlled trial was carried out at the Department of Anaesthesia, Aga Khan University Hospital, after approval from the ethical review committee. Sample size was calculated to be 86 (43 in each arm receiving either ketamine or saline) using 80% power at 5% level of significance assuming a 30% difference in the mean narcotic consumption in the ketamine group as compared to the control group using NCSS~Pass (version, 11.04).

ASA I and II patients undergoing laparoscopic cholecystectomy between 25 to 60 years of age were randomly selected and informed consent was taken. Patients having psychological problems, seizures or any CNS disease, history of substance abuse, allergy to ketamine and pethidine, pregnancy, cardiovascular, hepatic or renal disease were excluded from the study.

Intraoperative analgesia was standardized in all patients by giving 3μgm/kg fentanyl at induction. Syringes containing 10 ml ketamine or normal saline were prepared and documented. Patients were randomly allocated by sealed envelopes into two groups. Group S was given placebo (saline) while group K was given ketamine 0.5mg/kg intravenously just after the wound closure.

Patient and the observer were blinded to the groups. Pain scores were documented in a proforma by using VAS as soon as patients were shifted to recovery room and repeated at 15 and 30 minutes interval. Pethidine 10 mg was administered intravenously as rescue analgesia whenever pain score was ≥ 4. Total pethidine consumption in initial 30 minutes of recovery stay was calculated and documented.

All patients were given supplemental oxygen in recovery room to prevent hypoxia. Tachycardia (heart rate ≥120bpm) and hypertension (SBP >140 mmHg) were managed by beta blockers.

All analyses were conducted using the Statistical Package for Social Science version 19 (SPSS Inc, Chicago, IL). Continuous data are presented as mean and standard deviation after normality testing by Kolmogorov-Smirnov and histogram and analyzed by independent sample t-test. Categorical data are presented as frequency and percentage and analyzed by Chi-square test or fisher exact test. Effect of the intervention on amount of pethidine consumption was assessed by general liner model and regression coefficient were reported. To assess whether the effect of the intervention differed over time, an interaction between time and intervention was tested. Effect of the intervention on pain (measured 5 times during the first postoperative day) was assessed using a generalized estimating equation with continuous time, exchangeable working correlation matrix structure. Main effects were time and intervention. Interaction between time and intervention was also tested. p≤0.05 was considered as significant.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blinded
Primary Purpose: Prevention
Condition  ICMJE Cholelithiasis
Intervention  ICMJE Drug: Ketamine Hydrochloride
Ketamine was given prior to wound closure.
Other Name: ketasol
Study Arms  ICMJE
  • Experimental: Ketamine group (Group K)
    Group K was given ketamine @ 0.5mg/kg (prepared by dilution in 0.9% normal saline in 10 ml syringe) at the time of wound closure.
    Intervention: Drug: Ketamine Hydrochloride
  • Saline group (Group S)
    Group S was given saline in 10 ml syringe
    Intervention: Drug: Ketamine Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2022)
86
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2013
Actual Primary Completion Date November 30, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • all ASA 1 and 2 patients undergoing Laparoscopic Cholecystectomy electively.

Exclusion Criteria:

  • Hepatic and renal disease and ASA 3 and 4 patients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05444777
Other Study ID Numbers  ICMJE 2387-Ane-ERC-12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Dr. Saima Rashid, Aga Khan University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aga Khan University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aga Khan University
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP