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

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.

Study Overview

• Status: Completed
• Conditions: Shivering
• Intervention / Treatment: Drug: Tramadol; Drug: Ketamine

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Syed Muhammad Abbas
    • Karachi, Sindh, Pakistan, 74200
      • Sindh Institute of Urology and Transplantation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Tramadol; Tramadol 1 mg/kg IV given 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering; Other Names: Ultram; Tramal
Active Comparator: 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.	Drug: Ketamine; Ketamine 0.5 mg/kg IV administered 5 minutes after spinal anesthesia for prevention of post-anesthesia shivering.; Other Names: Ketalar; Ketaset

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and Severity of Post-Spinal Anesthesia Shivering	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	Up to 60 minutes post spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation Score	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.	Up to 60 minutes post spinal anesthesia
Incidence of Postoperative Nausea and Vomiting (PONV)	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.	Up to 60 minutes post spinal anesthesia

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue Analgesic Use	Administration of rescue pethidine (0.35 mg/kg IV) for Grade 3 shivering lasting more than 15 minutes will be recorded.	Within 60 minutes post spinal anesthesia
Adverse Events Monitoring	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.	Intraoperative and up to 60 minutes post spinal anesthesia

Collaborators and Investigators

• Sponsor: Syed Muhammad Abbas
• Investigators: Study Director: Muhammad Q Abbas, MCPS, FCPS, Sindh Institute of Urology and Transplantation

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 28, 2025
• First Submitted That Met QC Criteria: June 20, 2025
• First Posted (Actual): June 29, 2025

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Spinal Anesthesia; Shivering
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Anesthetics, Intravenous; Anesthetics, General; Excitatory Amino Acid Agents; Anesthetics, Dissociative; Excitatory Amino Acid Antagonists; Ketamine; Tramadol
• Other Study ID Numbers: SIUT-ERC-2021/A-326 (Other Identifier: Sindh Institute of Urology and Transplantation, Pakistan)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No