Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering.

NCT04870541 | Unknown Phase 4

• 1 other identifier: HDF15891
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia affects the homeostatic systems resulting in intraoperative hypothermia and subsequently shivering. In fact, shivering may be seen after this technique in 30 to 40% of cases . Ondansetron and Nefopam have been used to prevent intraoperative shivering . However, no prospective, randomized, double-blind study has been conducted to this date in order to compare nefopam with ondansetron in the prevention of post-spinal anesthesia shivering. The primary objective of this prospective, randomized, double-blind study is to compare the incidence and intensity of shivering after spinal anesthesia for non-obstetric surgery in 2 groups of patients. Group A: Patients receiving 8 mg of ondansetron diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater(75 patients). • Group B: Patients receiving 20 mg of nefopam diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater (75 patients)

Conditions

Shivering; Adverse Effects in the Therapeutic Use of Anaesthetic

Outcome Measures

Primary Outcomes (2)

• Incidence of shivering

  Number of episodes of shivering and variation will be noted every 15 minutes from drug administration up to 120 minutes.

  Shivering score was noted every 15 minutes from drug administration up to 120 minutes.

• Grade of shivering

  Grades of shivering will be noted every 15 minutes from drug administration up to 120 minutes. Shivering will be graded : 0 = no shivering, 1= piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 = shivering involving the whole body.

  Shivering score was noted every 15 minutes from drug administration up to 120 minutes.

Secondary Outcomes (3)

• Nausea/Vomitting

  Every 15 minutes from drug administration up to 120 minutes

• Hypotention/Bradycardia

  Every three minutes from drug administration up to 120 minutes.

• Pain on injection site by analogue visual scale.

  During administration of drug.

Study Arms (2)

Patients receiving Ondansetron

ACTIVE COMPARATOR

Drug: Ondansetron 8mg

Patients receiving Nefopam

ACTIVE COMPARATOR

Drug: Nefopam Injectable Solution

Interventions

Ondansetron 8mg DRUG

Patients receiving 8 mg of ondansetron diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater(75 patients).

Patients receiving Ondansetron

Nefopam Injectable Solution DRUG

Patients receiving 20 mg of nefopam diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater (75 patients)

Patients receiving Nefopam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 65 years
• scheduled for a surgery under spinal anesthesia

You may not qualify if:

• pregnant or breastfeeding (for the women), if they are
• Allergy to any of the drugs to be used
• Long QT syndrome
• Hepatic insufficiency
• Renal failure
• Parkinson's disease
• Epilepsy
• Glaucoma
• Phenylketonuria

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Universite Saint Joseph , Hotel Dieu de France

Beirut, Lebanon

RECRUITING

Related Publications (7)

• Kang P, Park SK, Yoo S, Hur M, Kim WH, Kim JT, Bahk JH. Comparative effectiveness of pharmacologic interventions to prevent shivering after surgery: a network meta-analysis. Minerva Anestesiol. 2019 Jan;85(1):60-70. doi: 10.23736/S0375-9393.18.12813-6. Epub 2018 Sep 18.

  PMID: 30226340 BACKGROUND

• Crowley LJ, Buggy DJ. Shivering and neuraxial anesthesia. Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006.

  PMID: 18433676 BACKGROUND

• Mathews S, Al Mulla A, Varghese PK, Radim K, Mumtaz S. Postanaesthetic shivering--a new look at tramadol. Anaesthesia. 2002 Apr;57(4):394-8. doi: 10.1046/j.1365-2044.2002.2457_3.x.

  PMID: 11949644 BACKGROUND

• Lv M, Wang X, Qu W, Liu M, Wang Y. Nefopam for the prevention of perioperative shivering: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2015 Jun 9;15:87. doi: 10.1186/s12871-015-0068-y.

  PMID: 26055978 BACKGROUND

• Rai S, Verma S, Pandey HP, Yadav P, Patel A. Role of butorphanol and ondansetron premedication in reducing postoperative shivering after general and spinal anesthesia: A randomized comparative study from North India. Anesth Essays Res. 2016 May-Aug;10(2):319-23. doi: 10.4103/0259-1162.172724.

  PMID: 27212768 BACKGROUND

• Marashi SM, Soltani-Omid S, Soltani Mohammadi S, Aghajani Y, Movafegh A. Comparing Two Different Doses of Intravenous Ondansetron With Placebo on Attenuation of Spinal-induced Hypotension and Shivering. Anesth Pain Med. 2014 Mar 18;4(2):e12055. doi: 10.5812/aapm.12055. eCollection 2014 May.

  PMID: 24790900 BACKGROUND

• Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients. Anesth Analg. 2001 Nov;93(5):1288-92. doi: 10.1097/00000539-200111000-00052.

  PMID: 11682416 BACKGROUND

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Christine Dagher, MD

CONTACT

+9613477332; chdagher@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: May 3, 2021
• Study Start: December 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)