Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine

Phase 4

Completed

• Conditions: Ketamine
• Interventions: Drug: Control group

• Registration Number: NCT04281628
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study Start: 2019-02-21
• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-24
• Primary Completion: 2020-05-20
• Study Completion: 2020-06-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	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.

Primary Outcome Measures

Name	Time	Method
total Amount of Morphine need intraoperative and postoperative	up to 24 hours	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University.; 🇪🇬 Cairo, Egypt