Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering.

Shivering Clinical Trial

Official title:

Comparative Study Between Nefopam and Ondansteron for Prevention of Post Spinal Shivering. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04870541
• Other study ID #: HDF15891
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: April 2021
• Source: Saint-Joseph University
• Contact: Christine Dagher, MD
• Phone: +9613477332
• Email: chdagher[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age between 18 and 65 years

• scheduled for a surgery under spinal anesthesia

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Shivering

Intervention

Drug:
• Ondansetron 8mg
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).
• Nefopam Injectable Solution
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)

Locations

Country	Name	City	State
Lebanon	Universite Saint Joseph , Hotel Dieu de France	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

References & Publications (7)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Nausea/Vomitting	Number of episodes of nausea and/or vomiting during and after surgery.	Every 15 minutes from drug administration up to 120 minutes
Secondary	Hypotention/Bradycardia	Hypotention: Number of episodes of hypotension SBP <90mmhg or <25% of baseline SBP in post spinal anesthesia until discharge from the PACU.; Bradycardia: Number of episodes of bradycardia <50 / min post-spinal anesthesia until discharge from the PACU.	Every three minutes from drug administration up to 120 minutes.
Secondary	Pain on injection site by analogue visual scale.	Pain upon administration of drug on site of injection will be assessed using the analogue visual scale .	During administration of drug.