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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Shivering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

The study medications were prepared in identical syringes by an independent anesthesiologist not involved in patient care to maintain blinding. Both the anesthesia providers and outcome assessors were blinded to group allocation throughout the study.

Study Groups

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Tramadol Group

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.

Group Type EXPERIMENTAL

Tramadol

Intervention Type DRUG

Tramadol 1 mg/kg IV given 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering

Ketamine Group

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Ketamine 0.5 mg/kg IV administered 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering.

Interventions

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Tramadol

Tramadol 1 mg/kg IV given 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering

Intervention Type DRUG

Ketamine

Ketamine 0.5 mg/kg IV administered 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering.

Intervention Type DRUG

Other Intervention Names

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Tramal Ultram Ketalar Ketaset

Eligibility Criteria

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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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes