Skip to content

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04281628
Enrollment
80
Registered
2020-02-24
Start date
2019-02-21
Completion date
2020-06-20
Last updated
2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ketamine

Keywords

Ketamine, Morphine, Laparotomy Myomectomy

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.

Interventions

DRUGKetamine 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.

DRUGControl group

where normal saline was administered as a loading dose then infused with same rate of another group, throughout the whole surgery.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
total Amount of Morphine need intraoperative and postoperativeup to 24 hoursadjusted 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

MeasureTime frameDescription
postoperative pain scoreup to 24 hoursassessment of patient by VAS sore 0= no pain , 10= sever pain
Number of Participants with hallucinationsup to 24 hourscomplication
duration of surgeryUP TO 1 HOUREtime from start to end
Number of Participants with nausea and vomitingup to 24 hourcomplication
Number of Participants with sedationup to 24 hourcomplication
Number of Participants with sleep disturbancesup to 24 hourscomplication

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026