Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine

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

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.

Study Overview

• Status: Completed
• Conditions: Ketamine
• Intervention / Treatment: Drug: Control group; Drug: Ketamine group:

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Faculty of medicine, Cairo University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; 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; where normal saline was administered as a loading dose then infused with same rate of another group, throughout the whole surgery.
Active Comparator: ketamine group; 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: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: amr wahadan, MD, lecture

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): June 20, 2020

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Ketamine; Morphine; Laparotomy Myomectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: I-190414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: still working

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No