Skip to main content
OpenTrials
Completed

NCT Number: NCT07043049

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shivering

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sindh Institute of Urology and Transplantation, Karachi, Sindh, Pakistan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tramadol

Drug

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

Other names: Tramal, Ultram

ketamine

Drug

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

Other names: Ketalar, Ketaset

Primary outcomes

  1. Incidence and Severity of Post-Spinal Anesthesia Shivering

    Time frame: Up to 60 minutes post spinal anesthesia

    The incidence and severity of shivering will be assessed using the Bedside Shivering Assessment Scale (BSAS) at 15, 30, 45, and 60 minutes following the administration of spinal anesthesia.

    BSAS Grading:

    • 0 = No shivering
    • 1 = Piloerection or peripheral vasoconstriction without visible shivering
    • 2 = Visible muscular activity confined to one muscle group
    • 3 = Gross muscular activity involving the entire body

Secondary outcomes

  1. Sedation Score

    Time frame: Up to 60 minutes post spinal anesthesia

    Sedation will be measured using the Ramsay Sedation Scale (RSS) at 15, 30, 45, and 60 minutes post spinal anesthesia.

    RSS scores range from 1 (anxious, agitated) to 6 (no response). Median and interquartile ranges will be calculated for each group.

  2. Incidence of Postoperative Nausea and Vomiting (PONV)

    Time frame: Up to 60 minutes post spinal anesthesia

    PONV will be assessed using the PONV Impact Scale at 15, 30, 45, and 60 minutes post spinal anesthesia. Presence or absence will be recorded at each time point.

Other outcomes

  1. Rescue Analgesic Use

    Time frame: Within 60 minutes post spinal anesthesia

    Administration of rescue pethidine (0.35 mg/kg IV) for Grade 3 shivering lasting more than 15 minutes will be recorded.

  2. Adverse Events Monitoring

    Time frame: Intraoperative and up to 60 minutes post spinal anesthesia

    Incidence of other side effects including hypotension, hypertension, hallucinations, and excessive sedation will be actively monitored and recorded intraoperatively and up to 60 minutes after spinal anesthesia.

Sponsors and collaborators

Lead sponsor

Syed Muhammad Abbas

Other

Registry information

Acronym: KETRA4PSAS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.