Prevention of Shivering After Spinal Anesthesia

NCT05718011 | Completed Phase 4

• 1 other identifier: PAFHIslamabad2
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Shivering

Keywords

Spinal anesthesia; Postoperative Shivering; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Postoperative Shivering

  Visible muscle activity in more than one muscle group.

  Change in every 10 minutes after spinal anesthesia till PACU discharge after 01 hour PACU stay.

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

0.5 micrograms/kg

Drug: Dexmedetomidine

ketamine

ACTIVE COMPARATOR

0.5 milligram/kg

Drug: Ketamine

Interventions

Dexmedetomidine DRUG

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

dexmedetomidine

Ketamine DRUG

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

ketamine

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 20-50 years.
• Both genders
• ASA physical status I and II
• Undergoing lower abdominal or lower limb surgeries under spinal anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Air Force (PAF) Hospital Islamabad: lead

Study Sites (1)

PAF Hospital Islamabad

Islamabad, Federal, 44230, Pakistan

Location

Related Publications (9)

• Bindu B, Bindra A, Rath G. Temperature management under general anesthesia: Compulsion or option. J Anaesthesiol Clin Pharmacol. 2017 Jul-Sep;33(3):306-316. doi: 10.4103/joacp.JOACP_334_16.

  PMID: 29109627 BACKGROUND

• Hoshijima H, Takeuchi R, Kuratani N, Nishizawa S, Denawa Y, Shiga T, Nagasaka H. Incidence of postoperative shivering comparing remifentanil with other opioids: a meta-analysis. J Clin Anesth. 2016 Aug;32:300-12. doi: 10.1016/j.jclinane.2015.08.017. Epub 2015 Oct 1.

  PMID: 26432635 BACKGROUND

• Choi KE, Park B, Moheet AM, Rosen A, Lahiri S, Rosengart A. Systematic Quality Assessment of Published Antishivering Protocols. Anesth Analg. 2017 May;124(5):1539-1546. doi: 10.1213/ANE.0000000000001571.

  PMID: 27622717 BACKGROUND

• Park SM, Mangat HS, Berger K, Rosengart AJ. Efficacy spectrum of antishivering medications: meta-analysis of randomized controlled trials. Crit Care Med. 2012 Nov;40(11):3070-82. doi: 10.1097/CCM.0b013e31825b931e.

  PMID: 22890247 BACKGROUND

• Leite MA, Orsini M, de Freitas MR, Pereira JS, Gobbi FH, Bastos VH, de Castro Machado D, Machado S, Arrias-Carrion O, de Souza JA, Oliveira AB. Another Perspective on Fasciculations: When is it not Caused by the Classic form of Amyotrophic Lateral Sclerosis or Progressive Spinal Atrophy? Neurol Int. 2014 Aug 8;6(3):5208. doi: 10.4081/ni.2014.5208. eCollection 2014 Aug 5.

  PMID: 25309711 BACKGROUND

• Buggy DJ, Crossley AW. Thermoregulation, mild perioperative hypothermia and postanaesthetic shivering. Br J Anaesth. 2000 May;84(5):615-28. doi: 10.1093/bja/84.5.615. No abstract available.

  PMID: 10844839 BACKGROUND

• Bozgeyik S, Mizrak A, Kilic E, Yendi F, Ugur BK. The effects of preemptive tramadol and dexmedetomidine on shivering during arthroscopy. Saudi J Anaesth. 2014 Apr;8(2):238-43. doi: 10.4103/1658-354X.130729.

  PMID: 24843340 BACKGROUND

• Lakhe G, Adhikari KM, Khatri K, Maharjan A, Bajracharya A, Khanal H. Prevention of Shivering during Spinal Anesthesia: Comparison between Tramadol, Ketamine and Ondansetron. JNMA J Nepal Med Assoc. 2017 Oct-Dec;56(208):395-400.

  PMID: 29453468 BACKGROUND

• Ameta N, Jacob M, Hasnain S, Ramesh G. Comparison of prophylactic use of ketamine, tramadol, and dexmedetomidine for prevention of shivering after spinal anesthesia. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):352-356. doi: 10.4103/joacp.JOACP_211_16.

  PMID: 30386019 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• ATIYA CHAUDHRY, MBBS

  PAF Hospital Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: February 8, 2023
• Study Start: February 20, 2021
• Primary Completion: August 19, 2021
• Study Completion: August 19, 2021
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)