Intravenous Dexmeditomidine for Prevention of Spinal Anesthesia Induced Shivering.

NCT ID: NCT05342376

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-12-31

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.

Detailed 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.

Conditions

Postoperative Shivering; Cesarean Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine

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..

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine Hydrochloride

Intervention Type: 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..

Saline

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

Group Type: ACTIVE_COMPARATOR

Normal Saline

Intervention Type: DRUG

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

Interventions

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..

Intervention Type: DRUG

Normal Saline

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

Intervention Type: DRUG

Other Intervention Names

inj Precidex (brookes pharmaceutical, Pakistan); Normal Saline 0.9 %

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rehman Medical Institute - RMI

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Shafiq

Consultant Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad Shafiq, FCPS

Role: PRINCIPAL_INVESTIGATOR

Rehman Medical Institute

Locations

Rehman Medical Institute

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Mohammad Shafiq, FCPS

Role: CONTACT

mohammad.shafiq@rmi.edu.pk

+92-91-5838000 ext. 2394

Rahman U Jan, MCPS

Role: CONTACT

janrahman21@gmail.com

+92-3339749567

Facility Contacts

Mohammad Shafiq, FCPS

Role: primary

mohammad.shafiq@rmi.edu.pk

+92-91-5838000 ext. 2394

Rahman U Jan, MCPS

Role: backup

janrahman21@gmail.com

+92-3339749567

References

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 10844839 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29109627 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9009941 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 4932622 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10417466 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10714846 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22450531 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 10730549 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18205960 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21876972 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 25024466 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17359402 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12421743 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22093385 (View on PubMed)

Other Identifiers

RMI/RMI-REC/Approval/58

Identifier Type: -

Identifier Source: org_study_id