NefopamNCT06627816
Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Post-Spinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries.
A study testing Nefopam in people with Nefopam and Dexmeditomidine, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This prospective, randomized, controlled, double-blinded study is designed to evaluate the efficacy of nefopam compared to dexmedetomidine and meperidine for the prevention of postspinal anesthesia shivering while minimizing side effects. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Nefopam, Dexmeditomidine, Meperidine
- What is being tested?
- Nefopam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2025to 5 Jul 2025
- Phase
- Interventional
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 21-60 undergoing elective lower abdominal, urological, gynecological, lower limb, orthopedic, or plastic surgeries under spinal anesthesia.
- ASA physical status I and II.
Who cannot join
- • Known hypersensitivity to nefopam, dexmedetomidine, or pethidine.
- Thyroid disorders, psychiatric disorders, severe diabetes, or autonomic neuropathies
- Known history of substance or alcohol abuse
- A history of convulsive disorders or severe neurological diseases
- Severe cardiac, pulmonary, renal, or hepatic disease
- Obstetric procedures and procedures requiring transfusion of blood and blood products.
- A contraindication to spinal anesthesia, e.g., coagulation disorders, local or general infection, increased intracranial tension, and progressive neurological disorders.
- Failed or partial spinal block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Post-Spinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries: A Double-Blind Comparative Study
This prospective, randomized, controlled, double-blinded study is designed to evaluate the efficacy of nefopam compared to dexmedetomidine and meperidine for the prevention of postspinal anesthesia shivering while minimizing side effects.
Read the detailed description
Numerous clinical studies have demonstrated that nefopam effectively prevents and treats postoperative shivering after general anesthesia. For instance, a dose of 0.15 mg/kg nefopam is comparable in efficacy to 0.5 µg/kg dexmedetomidine for treating shivering after orthopedic or abdominal surgery. Additionally, 20 mg of nefopam is equally effective as 50 mg of meperidine in preventing shivering following certain neurosurgical procedures . Notably, patients administered nefopam experience less sedation and hypotension compared to those given dexmedetomidine. However, further research is needed to evaluate nefopam's effects on preventing shivering after neuraxial blockades.
- Conditions
- Nefopam, Dexmeditomidine, Meperidine, Post-spinal Anesthesia Shivering
- Being tested
- Nefopam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NefopamDrug
Also called dexmeditomidine, meperidine
efficacy of 3 drugs in preventing post-spinal anesthesia shivering
| Study group | Role | What they receive |
|---|---|---|
| nefopam group | Active comparator | • Group N (n=80) will receive nefopam 0.15 mg/kg i.v. (Nopain®, Medical Union Pharmaceuticals MUP, Ismailia, Egypt, Ampoules of 20 mg/1 ml) Receives: Drug: Nefopam |
| dexmeditomidine group | Active comparator | • Group D (n=80) will receive dexmedetomidine 0.5 µg/kg i.v. (Precedex®, Hospira Inc, USA, Vials of 200 mg/2 ml) Receives: Drug: Nefopam |
| meperidine group | Active comparator | • Group P (n =80) will receive pethidine (meperidine) 0.5 mg/kg i.v. (Ampoules of 50 mg/1 ml). Receives: Drug: Nefopam |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of shivering during the whole observation period
shivering score ≥ 3. The shivering score will be assessed at 10-minute intervals after the spinal block and graded by the scale validated by Wrench et al.
Measured: 120 minutes
Secondary outcomes (3)
- Intraoperative hemodynamic variables
- (HR, MAP, SPO2) every 15 minutes
Measured: 120 minutes
axillary body temperature
every 30 minutes
Measured: 120 minutes
recurrent shivering
response to treatment
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start10 Jan 2025
- Primary completion30 Jun 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NefopamStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparative study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Ahmed Eissa, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627816
- Sponsor's protocol ID
- N-343-2024
- Status last verified
- Jul 2025
- First submitted
- 3 Oct 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelhafez EM, El-Siory W, Turki D, Eissa AA. Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Postspinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries: A Double-Blind Comparative Study. Anesthesiol Res Pract. 2025 Dec 3;2025:4549345. doi: 10.1155/anrp/4549345. eCollection 2025.
PubMed 41346412
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Post-Spinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries: A Double-Blind Comparative Study
- ClinicalTrials.gov ID
- NCT06627816
- Acronym / sponsor ID
- N-343-2024
- Conditions
- Nefopam, Dexmeditomidine, Meperidine, Post-spinal Anesthesia Shivering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 4 Oct 2024 (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.
This prospective, randomized, controlled, double-blinded study is designed to evaluate the efficacy of nefopam compared to dexmedetomidine and meperidine for the prevention of postspinal anesthesia shivering while minimizing side effects.
Detailed description
Numerous clinical studies have demonstrated that nefopam effectively prevents and treats postoperative shivering after general anesthesia. For instance, a dose of 0.15 mg/kg nefopam is comparable in efficacy to 0.5 µg/kg dexmedetomidine for treating shivering after orthopedic or abdominal surgery. Additionally, 20 mg of nefopam is equally effective as 50 mg of meperidine in preventing shivering following certain neurosurgical procedures . Notably, patients administered nefopam experience less sedation and hypotension compared to those given dexmedetomidine. However, further research is needed to evaluate nefopam's effects on preventing shivering after neuraxial blockades.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- comparative study
| Arm | Type | Receives |
|---|---|---|
| nefopam group | Active comparator | Drug: Nefopam• Group N (n=80) will receive nefopam 0.15 mg/kg i.v. (Nopain®, Medical Union Pharmaceuticals MUP, Ismailia, Egypt, Ampoules of 20 mg/1 ml) |
| dexmeditomidine group | Active comparator | Drug: Nefopam• Group D (n=80) will receive dexmedetomidine 0.5 µg/kg i.v. (Precedex®, Hospira Inc, USA, Vials of 200 mg/2 ml) |
| meperidine group | Active comparator | Drug: Nefopam• Group P (n =80) will receive pethidine (meperidine) 0.5 mg/kg i.v. (Ampoules of 50 mg/1 ml). |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients aged 21-60 undergoing elective lower abdominal, urological, gynecological, lower limb, orthopedic, or plastic surgeries under spinal anesthesia.
Key exclusion criteria (8 listed)
- • Known hypersensitivity to nefopam, dexmedetomidine, or pethidine.
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 |
|---|---|---|
| NefopamAlso: dexmeditomidine, meperidineefficacy of 3 drugs in preventing post-spinal anesthesia shivering | Drug | dexmeditomidine group, meperidine group, nefopam group |
Primary outcome
the incidence of shivering during the whole observation period
Time frame: 120 minutes
shivering score ≥ 3. The shivering score will be assessed at 10-minute intervals after the spinal block and graded by the scale validated by Wrench et al.
3 secondary outcomes
- Intraoperative hemodynamic variables
Time frame: 120 minutes
axillary body temperature
Time frame: 120 minutes
recurrent shivering
Time frame: 120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Derived from this study: PubMed 41346412Abdelhafez EM, El-Siory W, Turki D, Eissa AA. Efficacy of Intravenous Nefopam, Dexmedetomidine, and Meperidine in Preventing Postspinal Anesthesia Shivering in Adult Patients Undergoing Lower Abdominal and Lower Limb Surgeries: A Double-Blind Comparative Study. Anesthesiol Res Pract. 2025 Dec 3;2025:4549345. doi: 10.1155/anrp/4549345. eCollection 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nefopam in people with Nefopam and Dexmeditomidine, run by Kasr El Aini Hospital at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 10 Jul 2025. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of shivering during the whole observation period (time frame: 120 minutes). 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 NCT06627816, which also lists 1 linked publication.
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 10 Jul 2025.