Intravenous Dexmeditomidine for Prevention of Spinal Anesthesia Induced Shivering.

NCT05342376 | Unknown Phase 4

• 1 other identifier: RMI/RMI-REC/Approval/58
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative and post operative shivering is a common problem encountered in operating rooms and recovery suites. Shivering under spinal anesthesia has an incidence of 40-60%. Shivering is not only uncomfortable for the patient; additionally it increases minute oxygen consumption, subjecting the patient to a higher risk of cardiovascular complications. A variety of drugs like pethidine, fentanyl, alfentanil, sufentanil, buprenorphine, doxapram, clonidine, and ketanserin, are reported to be effective in suppressing postoperative shivering, yet an ideal drug/ method to be explored. Dexmeditomidine, a sedative and analgesic, may control shivering without significant adverse effects, like nausea and vomitting and respiratory depression. The study design will be randomized controlled parallel trials with sample size of 80,They will be randomized into two equal groups. One group will receive 10 microgram Inj. Dexmeditomedine while the other will recieve inj. normal saline as placebo. The participants will be assessed for intra- and postoperative shivering.

Conditions

Postoperative Shivering; Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• Rate of shivering in all parturients who received either Dexmeditomidine HCL or placebo

  The intensity of postoperative shivering will be graded using Bedside Shivering Assessment Scale(BSAS) from 0 - 3 with 0= no shivering and 3=severe shivering.

  Two hours

Secondary Outcomes (3)

• Rate of sedation in all parturients who received either Dexmedetomidine HCL or placebo.

  Two hours

• Rate of postoperative pain and analgesia in all parturients who received either Dexmeditomidine HCL or placebo.

  Two hours

• Incidence of adverse reactions associated with Dexmedetomidine HCL

  Two hours

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

This is group D, which will receive 10 micro-gram Dexmeditomidine diluted in 02 ml normal saline to be administered intravenously in 10 minutes after umbilical cord is clamped..

Drug: Dexmedetomidine Hydrochloride

Saline

ACTIVE COMPARATOR

This group S will receive 02 ml normal saline intravenously as placebo in 10 minutes after umbilical cord is clamped..

Drug: Normal Saline

Interventions

Dexmedetomidine Hydrochloride DRUG

The parturients will receive 10 micro-gram Dexmedetomidine diluted in 02 ml normal saline to be administered intravenously over 10 minutes after umbilical cord is clamped..

Also known as: inj Precidex (brookes pharmaceutical, Pakistan)

Dexmedetomidine

Normal Saline DRUG

The parturients will receive 02 ml normal saline as placebo, to be administered intravenously over 10 minutes after umbilical cord is clamped.

Also known as: Normal Saline 0.9 %

Saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Childbearing female, parturients presenting for Cesarean delivery.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I and II ladies
• Singleton pregnancies.
• Undergoing elective Cesarean delivery under spinal anesthesia.
• Systolic blood pressure ≥ 100 mm of Hg after umbilical cord clamping

You may not qualify if:

• ASA class III or above
• Hyperthyroidism
• Cardiopulmonary or respiratory disease
• A psychological disorder
• An initial body temperature of \>37.5 °C or \<36.5 °C
• Systolic blood pressure \<100 mm of Hg after umbilical cord clamping and/or mean arterial pressure (MAP) \< 65 mm of Hg after umbilical cord clamping

Sponsors & Collaborators

• Rehman Medical Institute - RMI: lead

Study Sites (1)

Rehman Medical Institute

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

RECRUITING

Related Publications (16)

• 2. Bhattacharya P, Bhattacharya L, Jain RK, Agarwal RC (2003) Postanaesthesia shivering (PAS): A review. Indian J Anaesth 47: 88-93.

  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

• 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

• Robinson BJ, Ebert TJ, O'Brien TJ, Colinco MD, Muzi M. Mechanisms whereby propofol mediates peripheral vasodilation in humans. Sympathoinhibition or direct vascular relaxation? Anesthesiology. 1997 Jan;86(1):64-72. doi: 10.1097/00000542-199701000-00010.

  PMID: 9009941 BACKGROUND

• Stevens WC, Cromwell TH, Halsey MJ, Eger EI 2nd, Shakespeare TF, Bahlman SH. The cardiovascular effects of a new inhalation anesthetic, Forane, in human volunteers at constant arterial carbon dioxide tension. Anesthesiology. 1971 Jul;35(1):8-16. doi: 10.1097/00000542-197107000-00005. No abstract available.

  PMID: 4932622 BACKGROUND

• Piper SN, Suttner SW, Schmidt CC, Maleck WH, Kumle B, Boldt J. Nefopam and clonidine in the prevention of postanaesthetic shivering. Anaesthesia. 1999 Jul;54(7):695-9. doi: 10.1046/j.1365-2044.1999.00849.x.

  PMID: 10417466 BACKGROUND

• Terasako K, Yamamoto M. Comparison between pentazocine, pethidine and placebo in the treatment of post-anesthetic shivering. Acta Anaesthesiol Scand. 2000 Mar;44(3):311-2. doi: 10.1034/j.1399-6576.2000.440316.x.

  PMID: 10714846 BACKGROUND

• Iwakiri H, Oda Y, Asada A, Ozaki M. The efficacy of continuous infusion of low dose dexmedetomidine for postoperative patients recovering in general wards. Eur J Anaesthesiol. 2012 May;29(5):251-4. doi: 10.1097/EJA.0b013e3283529ba8. No abstract available.

  PMID: 22450531 BACKGROUND

• Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.

  PMID: 10730549 BACKGROUND

• Elvan EG, Oc B, Uzun S, Karabulut E, Coskun F, Aypar U. Dexmedetomidine and postoperative shivering in patients undergoing elective abdominal hysterectomy. Eur J Anaesthesiol. 2008 May;25(5):357-64. doi: 10.1017/S0265021507003110. Epub 2008 Jan 21.

  PMID: 18205960 BACKGROUND

• Usta B, Gozdemir M, Demircioglu RI, Muslu B, Sert H, Yaldiz A. Dexmedetomidine for the prevention of shivering during spinal anesthesia. Clinics (Sao Paulo). 2011;66(7):1187-91. doi: 10.1590/s1807-59322011000700011.

  PMID: 21876972 BACKGROUND

• Günaydın B, Özköse Z, Tarhan B. Intravenous dexmedetomidine sedation for spinal anesthesia in the prone knee-chest position for lumbar laminectomy surgery. Turk J Med Sci 2004; 34: 353-5.

  BACKGROUND

• Mittal G, Gupta K, Katyal S, Kaushal S. Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering. Indian J Anaesth. 2014 May;58(3):257-62. doi: 10.4103/0019-5049.135031.

  PMID: 25024466 BACKGROUND

• Blaine Easley R, Brady KM, Tobias JD. Dexmedetomidine for the treatment of postanesthesia shivering in children. Paediatr Anaesth. 2007 Apr;17(4):341-6. doi: 10.1111/j.1460-9592.2006.02100.x.

  PMID: 17359402 BACKGROUND

• Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.

  PMID: 12421743 BACKGROUND

• Moola S, Lockwood C. Effectiveness of strategies for the management and/or prevention of hypothermia within the adult perioperative environment. Int J Evid Based Healthc. 2011 Dec;9(4):337-45. doi: 10.1111/j.1744-1609.2011.00227.x.

  PMID: 22093385 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mohammad Shafiq, FCPS

  Rehman Medical Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Shafiq, FCPS

CONTACT

+92-91-5838000; mohammad.shafiq@rmi.edu.pk

Rahman U Jan, MCPS

CONTACT

+92-3339749567; janrahman21@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Two color coded envelops containing drug and placebo.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologist

Model Details: Parallel Assignment The study design is prospective double-blinded randomized controlled parallel trial with allocation ratio of 1:1.

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 22, 2022
• Study Start: February 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: April, 2022 to April, 2025
• Access Criteria: IPD will be shared on inter institutional request basis.

Locations

PA (1)