Completed

Comparison of Prophylactic Use of Dexmedetomidine and Ketamine for Prevention of Shivering After Spinal Anesthesia

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What is being tested

Dexmedetomidine

+ Ketamine

Drug
Who is being recruted

From 20 to 50 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Phase 4
Interventional
Study Start: February 2021
See protocol details

Summary

Principal SponsorPakistan Air Force (PAF) Hospital Islamabad
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 20, 2021

Actual date on which the first participant was enrolled.

Spinal anaesthesia is a safe and popular anaesthetic technique for various surgeries. Around 40-60% of the patients under spinal anaesthesia develop shivering.The main causes of shivering intra and postoperatively are temperature loss, decreased sympathetic tone and systemic release of pyrogens. Hypothermia during neuraxial anesthesia develops initially from core to peripheral redistribution of body heat. Redistribution of body heat during spinal or epidural anesthesia typically decreases core body temperature 0.5-1.0 degree Celsius. Shivering is characterised by involuntary oscillatory contractions of skeletal muscles. Once the body is exposed to cold, it is a physiological response for heat preservation after peripheral vasoconstriction. Postoperative shivering is defined as the fasciculation of the face, jaw or head or muscle hyperactivity, lasting longer than 15 seconds. It is a common and challenging aspect of anaesthesia and targeted temperature modulation because it leads to increase oxygen consumption and increases the risk of hypoxia. The most frequent complication in postoperative period is shivering which is reported to be between 20-70% after general anaesthesia. The incidence reported in previous studies are 5-65% after general anaesthesia and 30-33% after epidural procedures. The overall shivering incidence in a recent meta-analysis was 34%. The underlying pathology of shivering is not fully understood yet, therefore the definitive treatment and prevention has not been established till date. Due to its importance as postoperative complication and the lack of available data about aetiology and treatment, this narrative review of the published literature on this topic is essential. Various pharmacological agents being used for prophylaxis and treatment of post spinal shivering are Opioids like fentanyl, tramadol, pethidine, Anticholinergics like physostigmine, NMDA receptor antagonist like ketamine and the latest being alpha-2 antagonists like clonidine, dexmedetomidine. Recently, ketamine and dexmedetomidine have been used to prevent shivering during anaesthesia, with good results. Ketamine (a competitive NMDA receptor antagonist) plays a role in thermoregulation at various levels and ketamine, has been shown to inhibit postoperative shivering in some reports and studies. Dexmedetomidine, a centrally acting alpha 2-adrenergic agonist, has been used as a sedative agent and is known to reduce the shivering threshold. Dexmedetomidine also provided sedation which is sufficient to prevent the anxiety without any adverse effects. And until date, there are limited studies using dexmedetomidine in the treatment of postoperative shivering. A very limited data is available on this subject in our Pakistani population. Pethidine is drug of choice for the prevention and treatment of shivering. Due to the non-availability of Pethidine, doctors are looking for newer and better options. Considering this, a study is designed to compare between Dexmedetomidine and Ketamine, as they are easily available and very few studies are done till date comparing them, as ketamine isn't researched much as an anti-shivering agent as it is known for undesirable side effects like delirium and hallucinations and dexmedetomidine being a newer agent. Results of this study will help to select the better prophylactic option for prevention of shivering after spinal anaesthesia in our general population.

Official TitleComparison of Prophylactic Use of Dexmedetomidine and Ketamine for Prevention of Shivering After Spinal Anesthesia
NCT05718011
Principal SponsorPakistan Air Force (PAF) Hospital Islamabad
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

116 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Patients aged 20-50 years.

Both genders

ASA physical status I and II

Undergoing lower abdominal or lower limb surgeries under spinal anaesthesia

5 exclusion criteria prevent from participating
Patients with history of thyroid and neuromuscular diseases

Patients with severe hypovolemia

Patients with febrile illness

Patients who required blood transfusion during surgery

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
0.5 micrograms/kg

Group II

Active Comparator
0.5 milligram/kg

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

PAF Hospital Islamabad

Islamabad, PakistanOpen PAF Hospital Islamabad in Google Maps
CompletedOne Study Center