Comparison of Prophylactic Use of Tramadol Versus Ketamine for Prevention of Post Spinal Anesthesia Shivering (KETRA4PSAS)

Syed Muhammad Abbas

Status and phase: Completed; Phase 3

Conditions: Shivering

Treatments: Drug: Tramadol; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT07043049

SIUT-ERC-2021/A-326 (Other Identifier)

Details and patient eligibility

About

The goal of this clinical trial is to compare the effectiveness of tramadol versus ketamine in preventing shivering after spinal anesthesia in adult patients (ages 20-65) undergoing elective lower abdominal or inguinoscrotal surgeries.

The main questions it aims to answer are:

• Does prophylactic intravenous tramadol reduce the incidence and severity of shivering more effectively than ketamine after spinal anesthesia?
• Are there differences in side effects, such as sedation or nausea, between tramadol and ketamine?

Researchers will compare the tramadol group to the ketamine group to see which drug is more effective and safer for shivering prevention.

Participants will:

• Be randomly assigned to receive either tramadol (1 mg/kg) or ketamine (0.5 mg/kg) five minutes after spinal anesthesia.
• Have their shivering severity assessed at 15, 30, 45, and 60 minutes using a standardized scale.
• Be monitored for sedation, nausea, and other possible side effects.

Enrollment: 92 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients aged 20 to 65 years,
2. American Society of Anesthesiologists (ASA) Physical Status I or II, and
3. Scheduled for elective lower abdominal or inguinoscrotal surgeries
4. Under spinal anesthesia were included

Exclusion criteria

1. Thyroid or neuromuscular disorders,
2. Pregnant
3. History of chronic sedative or narcotic use,
4. Requiring intraoperative blood transfusion
5. Had a baseline body temperature greater than 38°C or less than 36°C,
6. Undergoing transurethral resection of the prostate (TURP).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

Tramadol Group

Experimental group

Description:

Patients in this group receive intravenous tramadol 1 mg/kg five minutes after the administration of spinal anesthesia. The intervention is administered in a double-blind manner using identical syringes prepared by an independent anesthesiologist.

Treatment:

Drug: Tramadol

Ketamine Group

Active Comparator group

Description:

Patients in this group receive intravenous ketamine 0.5 mg/kg five minutes after spinal anesthesia, using identical administration procedures to maintain blinding.

Treatment:

Drug: Ketamine