Intravenous Dexmeditomidine for Prevention of Spinal Anesthesia Induced Shivering.

Cesarean Delivery Clinical Trial

Official title:

Role of Dexmeditomidine HCL for Prevention of Shivering in Obstetrical Spinal Anesthesia, a Randomized Controlled Double Blind Parallel Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05342376
• Other study ID #: RMI/RMI-REC/Approval/58
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Rehman Medical Institute - RMI
• Contact: Mohammad Shafiq, FCPS
• Phone: +92-91-5838000
• Email: mohammad.shafiq[@]rmi.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Intraoperative inadvertent changes in the body temperature are quite common. Incidence of inadvertent hypothermia (up to 90%) is much higher than hyperthermia. The hypothermic patients shiver postoperatively after general anesthesia and both introperatively and post operatively during regional anesthesia. Shivering under spinal anesthesia has an incidence of 40-60%. Shivering is not only uncomfortable for the patient; additionally it increases minute oxygen consumption VO2 at the cost of increased presser hormones level, subjecting the patient to a higher risk of cardiovascular complications. Heat loss from skin and surgical site is mostly by radiation. Dropped body temperature in cesarean section under spinal anesthesia is due to a combination of anesthetic-induced impaired thermoregulation i.e. vasodilation and inhibition of vasoconstriction in the blocked dermatomes, which are due to autonomic and motor blockade caused by spinal anesthesia. General anesthesia also leads to hypothermia due to vasodilation and reduced metabolic rate, in the order of 20%-30%. Additional factors are exposure to cold environment, un-warmed cold irrigants/ intra vascular fluids and ventilation with dry anesthetic gases. In spinal anesthesia, due to blocked motor activity below umbilicus, shivering in response to hypothermia is abolished. It interferes with physiologic heat recovery, as human core body temperature should normally be maintained within the narrow range of 36.5-37.5 °C. 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 which is an alpha-2 agonist, is a new drug used for analgesia and sedation either in perioperative settings or in intensive care units. It is 7-8 times selective alpha 2 agonist than clonidine and was expected to control shivering like clonidine. There are study demonstrating the favorable effect of Dexmeditomidine via infusion in the intraoperative period on shivering after abdominal hysterectomy. In previous studies, a prophylactic single dose of Dexmeditomidine for prevention or aborting shivering was generally found to be effective after general or regional anesthesia. Dexmedetomidine 0.5 mcg/kg I/v as loading dose was found 100% effective in managing post anesthesia shivering after general anesthesia in children. In another study, it was observed that Dexmedetomidine was equally effective compared to tramadol, and was associated with shorter time for complete shivering control and less incidence of nausea vomiting, but prospects of a single sub loading dose in parturients during spinal anesthesia requires exploration as physiologic volume loaded parturients at term are expected to lose more heat by redistribution due to vasodilation caused by spinal anesthesia.

OBJECTIVE: To determine the role of single sub loading dose of Dexmeditomidine i.e. 10 mcg (0.1- 0.2 microgram/kg) administered intravenously for prevention of shivering in participants undergoing Cesarean section under spinal anesthesia in a randomized double-blind, placebo controlled parallel study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Cesarean Delivery
• Postoperative Shivering

Intervention

Drug:
• Dexmedetomidine Hydrochloride
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..
• Normal Saline
The parturients will receive 02 ml normal saline as placebo, to be administered intravenously over 10 minutes after umbilical cord is clamped.

Locations

Country	Name	City	State
Pakistan	Rehman Medical Institute	Peshawar	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
Rehman Medical Institute - RMI

Country where clinical trial is conducted

Pakistan, 

References & Publications (16)

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

Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. — View Citation

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. Review. — View Citation

Blaine Easley R, Brady KM, Tobias JD. Dexmedetomidine for the treatment of postanesthesia shivering in children. Paediatr Anaesth. 2007 Apr;17(4):341-6. — View Citation

Buggy DJ, Crossley AW. Thermoregulation, mild perioperative hypothermia and postanaesthetic shivering. Br J Anaesth. 2000 May;84(5):615-28. Review. — View Citation

Elvan EG, Oç 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. — View Citation

Günaydin 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.

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Retraction in: Anaesthesia. 2011 Jul;66(7):647. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of sedation in all parturients who received either Dexmedetomidine HCL or placebo.	Sedation will be assessed through Richmond agitation sedation scale (RASS) from +4 to - 5 with +4= combative and -5= unarousable.	Two hours
Secondary	Rate of postoperative pain and analgesia in all parturients who received either Dexmeditomidine HCL or placebo.	Postoperative pain/analgesia will be assessed through visual analogue scale (VAS) with 0= no pain, 100= very severe pain.	Two hours
Secondary	Incidence of adverse reactions associated with Dexmedetomidine HCL	Incidence of adverse reactions like hypotension and bradycardia in Dexmedetomidine group will be noted and compared with saline group	Two hours