Clinical trial NCT04281628: Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine
Official title: Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine Infusion for Analgesia in Laparotomy Myomectomy: A Double-blind, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ketamine
Keywords: Ketamine
Morphine
Laparotomy Myomectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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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Primary outcomes:
measure: total Amount of Morphine need intraoperative and postoperative
timeFrame: up to 24 hours
Secondary outcomes:
measure: duration of surgery
timeFrame: UP TO 1 HOURE
measure: postoperative pain score
timeFrame: up to 24 hours
measure: Number of Participants with hallucinations
timeFrame: up to 24 hours
measure: Number of Participants with sleep disturbances
timeFrame: up to 24 hours
measure: Number of Participants with nausea and vomiting
timeFrame: up to 24 hour
measure: Number of Participants with sedation
timeFrame: up to 24 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University.
Study officials:
affiliation: lecture
name: amr wahadan, MD
role: PRINCIPAL_INVESTIGATOR
References: