Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine

Study Overview
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Brief Summary
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Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with excellent analgesic property even in subanesthetic doses. It is readily available and is being used currently, even by non-Anesthesiologists, to provide sedation for minor procedures.(.. Low-dose ketamine infusion in the perioperative period has shown to produce analgesia and decrease the requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an inadequately functioning spinal anesthesia for caesarean section, as an induction agent for cesarean section and also to provide analgesia during labor in intermittent boluses.

Detailed Description
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Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with excellent analgesic property even in subanesthetic doses. It is readily available and is being used currently, even by non-Anesthesiologists, to provide sedation for minor procedures.(.. Low-dose ketamine infusion in the perioperative period has shown to produce analgesia and decrease the requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an inadequately functioning spinal anesthesia for caesarean section, as an induction agent for cesarean section and also to provide analgesia during labor in intermittent boluses.

Official Title
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Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine Infusion for Analgesia in Laparotomy Myomectomy: A Double-blind, Randomized, Controlled Clinical Trial

Conditions
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Ketamine

Intervention / Treatment
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* Drug: Ketamine group:
* Drug: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: The study will include 80 ASA physical status I, II patients with age between 18- 50 years old scheduled for elective myomectomy under general anesthesia Exclusion criteria: Patients who refused to participate, ASA physical status III, IV, patients younger than 18 years or > 50 years old, BMI > 30, history of epilepsy. Patients having a history of parenteral or oral analgesics within the last 24 hours before initiation of operation or those having allergy to study agents will be excluded. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>control group: where normal saline will be administered as a loading dose then infused with same rate of another group, throughout the whole surgery. | Drug: Control group<br>* where normal saline was administered as a loading dose then infused with same rate of another group, throughout the whole surgery.<br>|
| Active Comparator: ketamine group<br>Ketamine group: will be administered ketamine in a loading dose of 0.2 mg/kg over 5 min pre incision followed-by an infusion at 0.2 mg/kg/h until the end of surgery. | Drug: Ketamine group:<br>* Ketamine group: will be administered ketamine in a loading dose of 0.2 mg/kg over 5 min pre incision followed-by an infusion at 0.2 mg/kg/h until the end of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total Amount of Morphine need intraoperative and postoperative | adjusted to keep the HR and mean arterial blood pressure within 20% of the pre induction values. Starting from the induction till the end of the operation. | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of surgery | time from start to end | UP TO 1 HOURE | 
| postoperative pain score | assessment of patient by VAS sore 0= no pain , 10= sever pain | up to 24 hours | 
| Number of Participants with hallucinations | complication | up to 24 hours | 
| Number of Participants with sleep disturbances | complication | up to 24 hours | 
| Number of Participants with nausea and vomiting | complication | up to 24 hour | 
| Number of Participants with sedation | complication | up to 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Morphine, Laparotomy Myomectomy