Prevention of Shivering After Spinal Anesthesia

Sponsor
Pakistan Air Force (PAF) Hospital Islamabad (Other)
Overall Status
Completed
CT.gov ID
NCT05718011
Collaborator
(none)
116
1
2
5.9
19.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Comparison of Prophylactic Use of Dexmedetomidine and Ketamine for Prevention of Shivering After Spinal Anesthesia
Actual Study Start Date :
Feb 20, 2021
Actual Primary Completion Date :
Aug 19, 2021
Actual Study Completion Date :
Aug 19, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: dexmedetomidine

0.5 micrograms/kg

Drug: Dexmedetomidine
0.5 micrograms/kg diluted in 10mL of normal saline 0.9% given as IV infusion over 10 minutes

Active Comparator: ketamine

0.5 milligram/kg

Drug: Ketamine
0.5 milligrams/kg diluted in 10mL of normal saline 0.9% given as IV infusion over 10 minutes

Outcome Measures

Primary Outcome Measures

  1. Postoperative Shivering [Change in every 10 minutes after spinal anesthesia till PACU discharge after 01 hour PACU stay.]

    Visible muscle activity in more than one muscle group.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients aged 20-50 years.

  • Both genders

  • ASA physical status I and II

  • Undergoing lower abdominal or lower limb surgeries under spinal anaesthesia

Exclusion Criteria:
  • Patients with history of thyroid and neuromuscular diseases

  • Patients with severe hypovolemia

  • Patients with febrile illness

  • Patients who required blood transfusion during surgery

  • Patients with body temperature ≤ 36˚C or ≥ 38˚C on thermometer

Contacts and Locations

Locations

Site City State Country Postal Code
1 PAF Hospital Islamabad Islamabad Federal Pakistan 44230

Sponsors and Collaborators

  • Pakistan Air Force (PAF) Hospital Islamabad

Investigators

  • Principal Investigator: ATIYA CHAUDHRY, MBBS, PAF Hospital Islamabad

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Pakistan Air Force (PAF) Hospital Islamabad
ClinicalTrials.gov Identifier:
NCT05718011
Other Study ID Numbers:
  • PAFHIslamabad2
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pakistan Air Force (PAF) Hospital Islamabad
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023