Clinical trial NCT04870541: Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering.
Official title: Comparative Study Between Nefopam and Ondansteron for Prevention of Post Spinal Shivering. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Shivering
Adverse Effects in the Therapeutic Use of Anaesthetic
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of shivering
timeFrame: Shivering score was noted every 15 minutes from drug administration up to 120 minutes.
measure: Grade of shivering
timeFrame: Shivering score was noted every 15 minutes from drug administration up to 120 minutes.
Secondary outcomes:
measure: Nausea/Vomitting
timeFrame: Every 15 minutes from drug administration up to 120 minutes
measure: Hypotention/Bradycardia
timeFrame: Every three minutes from drug administration up to 120 minutes.
measure: Pain on injection site by analogue visual scale.
timeFrame: During administration of drug.
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Universite Saint Joseph , Hotel Dieu de France
Study officials:
References:
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.
citation: 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.
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. doi: 10.1046/j.1365-2044.2002.2457_3.x.
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.
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.
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.
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. doi: 10.1097/00000539-200111000-00052.