ShiveringPhase 4NCT04870541
Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering.
A Phase 4 study testing Ondansetron 8mg and Nefopam Injectable Solution in people with Shivering and Adverse Effects in the Therapeutic Use of Anaesthetic, run by Saint-Joseph University at 1 site in Lebanon.
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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shivering, Adverse Effects in the Therapeutic Use of Anaesthetic
- What is being tested?
- Ondansetron 8mg and Nefopam Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Dec 2020to 1 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 65 years
- scheduled for a surgery under spinal anesthesia
Who cannot join
- 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
Show all 9Show fewer
- Epilepsy
- Glaucoma
- Phenylketonuria
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Universite Saint Joseph , Hotel Dieu de France
Beirut
Christine Dagher, MD, +9613477332, chdagher@hotmail.com
About this study
Official title: Comparative Study Between Nefopam and Ondansteron for Prevention of Post Spinal Shivering. A Randomized Controlled Trial.
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.
Read more
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)
- Being tested
- Ondansetron 8mg, Nefopam Injectable Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 8mgDrug
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 SolutionDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving Ondansetron | Active comparator | Not described Receives: Drug: Ondansetron 8mg |
| Patients receiving Nefopam | Active comparator | Not described Receives: Drug: Nefopam Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of shivering
Number of episodes of shivering and variation will be noted every 15 minutes from drug administration up to 120 minutes.
Measured: 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.
Measured: Shivering score was noted every 15 minutes from drug administration up to 120 minutes.
Secondary outcomes (3)
Nausea/Vomitting
Number of episodes of nausea and/or vomiting during and after surgery.
Measured: Every 15 minutes from drug administration up to 120 minutes
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.
Measured: Every three minutes from drug administration up to 120 minutes.
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 .
Measured: During administration of drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start1 Dec 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ShiveringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870541
- Sponsor's protocol ID
- HDF15891
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2021
- Last updated
- 3 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30226340Crowley 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.
PubMed 18433676Mathews 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.
PubMed 11949644Lv 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.
PubMed 26055978Rai 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.
PubMed 27212768Marashi 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.
PubMed 24790900Tsai 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.
PubMed 11682416Tohme J, Chehade J, Abou Zeid H, Mattar R, Naccache N, Jabbour K, Ismail MA, Dagher C. Prevention of shivering post spinal anesthesia: Ondansetron vs. Nefopam - a prospective randomized controlled trial. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844650. doi: 10.1016/j.bjane.2025.844650. Epub 2025 Jun 11.
PubMed 40513826
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Nefopam and Ondansteron for Prevention of Post Spinal Shivering. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04870541
- Acronym / sponsor ID
- HDF15891
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Ondansetron | Active comparator | Drug: Ondansetron 8mg |
| Patients receiving Nefopam | Active comparator | Drug: Nefopam Injectable Solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 18 and 65 years
- scheduled for a surgery under spinal anesthesia
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron 8mgPatients 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). | Drug | Patients receiving Ondansetron |
| Nefopam Injectable SolutionPatients 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) | Drug | Patients receiving Nefopam |
Primary outcome
Incidence of shivering
Time frame: Shivering score was noted every 15 minutes from drug administration up to 120 minutes.
Number of episodes of shivering and variation will be noted every 15 minutes from drug administration up to 120 minutes.
Grade of shivering
Time frame: Shivering score was noted every 15 minutes from drug administration up to 120 minutes.
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.
3 secondary outcomes
Nausea/Vomitting
Time frame: Every 15 minutes from drug administration up to 120 minutes
Hypotention/Bradycardia
Time frame: Every three minutes from drug administration up to 120 minutes.
Pain on injection site by analogue visual scale.
Time frame: During administration of drug.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Background: PubMed 30226340Kang 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.
- Background: PubMed 18433676Crowley 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.
- Background: PubMed 11949644Mathews 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.
- Background: PubMed 26055978Lv 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.
- Background: PubMed 27212768Rai 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.
- Background: PubMed 24790900Marashi 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.
- Background: PubMed 11682416Tsai 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.
- Derived from this study: PubMed 40513826Tohme J, Chehade J, Abou Zeid H, Mattar R, Naccache N, Jabbour K, Ismail MA, Dagher C. Prevention of shivering post spinal anesthesia: Ondansetron vs. Nefopam - a prospective randomized controlled trial. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844650. doi: 10.1016/j.bjane.2025.844650. Epub 2025 Jun 11.
- Individual participant dataSharing planned: No
Related trials for Shivering
Not yet recruitingPhase 4
Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
Not yet recruiting
Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
Perioperative Hypothermia, Hernia, Inguinal
Not yet recruiting
Resistive Versus Forced-Air Warming for Prevention of Perioperative Hypothermia
Perioperative Hypothermia, Inadvertent Perioperative Hypothermia
Recruiting
Effect Of Acupressure On Hypothermıa And Shıverıng After Cesarean Sectıon
Hypothermia, Shivering
Not yet recruitingPhase 4
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Shivering, Postoperative Shivering
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron 8mg and Nefopam Injectable Solution in people with Shivering and Adverse Effects in the Therapeutic Use of Anaesthetic, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Dagher, MD (+9613477332, chdagher@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of shivering (time frame: Shivering score was noted every 15 minutes from drug administration up to 120 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04870541, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.