Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Ketamine

Treatments: Drug: Ketamine group:; Drug: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT04281628

I-190414

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Control group

ketamine group

Active Comparator group

Description:

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.

Treatment:

Drug: Ketamine group: