ShiveringPhase 4NCT07855536
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
A Phase 4 study testing Dexmedetomidine, Meperidine and Normal Saline 0.9% in people with Shivering and Hypothermia, run by Assiut University.
Trial summary
Shivering is a common and distressing complication occurring in 40% to 60% of women undergoing cesarean section under spinal anesthesia. Beyond causing significant maternal discomfort, shivering markedly increases oxygen consumption and metabolic demand, elevates cardiopulmonary workload, and interferes with clinical… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Shivering, Hypothermia, Cesarean Section
- What is being tested?
- Dexmedetomidine, Meperidine and Normal Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18 to 40 years.
- American Society of Anesthesiologists (ASA) physical status II.
- Term singleton pregnancy.
- Scheduled for elective cesarean section under spinal anesthesia.
Who cannot join
- Refusal to participate.
- Contraindications to spinal anesthesia.
- Nasal pathology preventing intranasal drug administration.
- Known allergy or hypersensitivity to any study medication (dexmedetomidine, meperidine, or bupivacaine).
- Significant cardiac disease.
- Renal or hepatic impairment.
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- Preeclampsia, eclampsia, or HELLP syndrome.
- Cesarean section requiring general anesthesia.
- Body mass index (BMI) > 40 kg/m².
About this study
Official title: Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia: Randomized Controlled Trial
Shivering is a common and distressing complication occurring in 40% to 60% of women undergoing cesarean section under spinal anesthesia. Beyond causing significant maternal discomfort, shivering markedly increases oxygen consumption and metabolic demand, elevates cardiopulmonary workload, and interferes with clinical monitoring. While intravenous meperidine remains a widely used pharmacological agent for shivering prophylaxis, it carries dose-dependent adverse effects such as nausea, vomiting, sedation, and potential neonatal depression. Intranasal dexmedetomidine provides an alternative needle-free method of administration that rapidly absorbs through the nasal mucosa and reduces shivering without suppressing respiratory drive.
The primary purpose of this randomized controlled trial is to evaluate the efficacy of preoperative intranasal dexmedetomidine in reducing the incidence of intraoperative shivering compared with intravenous meperidine and placebo in women undergoing elective cesarean section under spinal anesthesia.
Read more
A total of 99 parturients will be randomly allocated to one of three parallel groups (33 patients per group) using a double-dummy design:
- Group D: Receives intranasal dexmedetomidine (1 mcg/kg) 30 minutes before spinal anesthesia, plus an intravenous saline placebo at spinal induction.
- Group M: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous meperidine (0.5 mg/kg) at spinal induction.
- Group C: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous saline placebo at spinal induction.
Participants will be monitored throughout the surgical procedure to determine the occurrence of shivering, maternal hemodynamic parameters (heart rate, blood pressure, oxygen saturation), sedation levels using the Richmond Agitation-Sedation Scale (RASS), need for rescue anti-shivering medication, side effects, and neonatal outcomes (Apgar scores and birth weight).
- Conditions
- Shivering, Hypothermia, Cesarean Section, Spinal Anaesthesia
- Being tested
- Dexmedetomidine, Meperidine, Normal Saline 0.9%
- Keywords
- Intranasal dexmedetomidine, Meperidine, Post-spinal shivering, Spinal anesthesia, Obstetric anesthesia, Thermoregulation
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Administered intranasally at a dose of 1 mcg/kg diluted in 2 mL normal saline 0.9% using a sterile dropper, instilled slowly into each nostril 30 minutes before induction of spinal anesthesia in the pre-anesthesia room.
MeperidineDrug
Administered as an intravenous bolus at a dose of 0.5 mg/kg diluted to a total volume of 10 mL normal saline 0.9% immediately before the induction of spinal anesthesia.
Normal Saline 0.9%Drug
Administered as an identical matching placebo within the double-dummy design: 2 mL intranasally (30 minutes prior to spinal anesthesia) and/or 10 mL as an intravenous bolus (immediately before spinal induction).
| Study group | Role | What they receive |
|---|---|---|
| Group D: Intranasal Dexmedetomidine | Experimental | Participants receive intranasal dexmedetomidine 1 mcg/kg diluted in 2 mL normal saline administered 30 minutes before induction of spinal anesthesia in the pre-anesthesia room, along with an intravenous bolus of 10 mL normal saline 0.9% immediately before spinal injection (double-dummy placebo) (n = 33). Receives: Drug: Dexmedetomidine; Drug: Normal Saline 0.9% |
| Group M: Intravenous Meperidine | Active comparator | Participants receive 2 mL normal saline 0.9% intranasally 30 minutes before induction of spinal anesthesia (double-dummy placebo), along with an intravenous bolus of meperidine 0.5 mg/kg diluted to 10 mL normal saline immediately before spinal injection (n = 33). Receives: Drug: Meperidine; Drug: Normal Saline 0.9% |
| Group C: Placebo Control | Placebo comparator | Participants receive 2 mL normal saline 0.9% intranasally 30 minutes before induction of spinal anesthesia, along with an intravenous bolus of 10 mL normal saline 0.9% immediately before spinal injection (n = 33). Receives: Drug: Normal Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Intraoperative Shivering
Participants will be assessed for the occurrence of intraoperative shivering using a 5-point scale: Grade 0 = no shivering; Grade 1 = piloerection, peripheral vasoconstriction, or cyanosis; Grade 2 = visible muscle activity confined to one muscle group; Grade 3 = visible muscle activity involving more than one muscle group; Grade 4 = gross muscle activity involving the whole body (scores range from 0 to 4, where 0 indicates no shivering and 4 indicates severe whole-body shivering). Shivering is defined as the occurrence of Grade 1 or higher at any time during the procedure.
Measured: Through completion of surgery, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShiveringStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beshoy Bahaa Basha Naeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855536
- Sponsor's protocol ID
- Nasal Dex for Shivering in CS
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07855536
- Acronym / sponsor ID
- Nasal Dex for Shivering in CS
- Conditions
- Shivering, Hypothermia, Cesarean Section, Spinal Anaesthesia
- Keywords
- Intranasal dexmedetomidine, Meperidine, Post-spinal shivering, Spinal anesthesia, Obstetric anesthesia, Thermoregulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Oct 2026 (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.
Shivering is a common and distressing complication occurring in 40% to 60% of women undergoing cesarean section under spinal anesthesia. Beyond causing significant maternal discomfort, shivering markedly increases oxygen consumption and metabolic demand, elevates cardiopulmonary workload, and interferes with clinical monitoring. While intravenous meperidine remains a widely used pharmacological agent for shivering prophylaxis, it carries dose-dependent adverse effects such as nausea, vomiting, sedation, and potential neonatal depression. Intranasal dexmedetomidine provides an alternative needle-free method of administration that rapidly absorbs through the nasal mucosa and reduces shivering without suppressing respiratory drive.
The primary purpose of this randomized controlled trial is to evaluate the efficacy of preoperative intranasal dexmedetomidine in reducing the incidence of intraoperative shivering compared with intravenous meperidine and placebo in women undergoing elective cesarean section under spinal anesthesia.
A total of 99 parturients will be randomly allocated to one of three parallel groups (33 patients per group) using a double-dummy design:
- Group D: Receives intranasal dexmedetomidine (1 mcg/kg) 30 minutes before spinal anesthesia, plus an intravenous saline placebo at spinal induction.
- Group M: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous meperidine (0.5 mg/kg) at spinal induction.
- Group C: Receives intranasal saline placebo 30 minutes before spinal anesthesia, plus intravenous saline placebo at spinal induction.
Participants will be monitored throughout the surgical procedure to determine the occurrence of shivering, maternal hemodynamic parameters (heart rate, blood pressure, oxygen saturation), sedation levels using the Richmond Agitation-Sedation Scale (RASS), need for rescue anti-shivering medication, side effects, and neonatal outcomes (Apgar scores and birth weight).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group D: Intranasal Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: Normal Saline 0.9%Participants receive intranasal dexmedetomidine 1 mcg/kg diluted in 2 mL normal saline administered 30 minutes before induction of spinal anesthesia in the pre-anesthesia room, along with an intravenous bolus of 10 mL normal saline 0.9% immediately before spinal injection (double-dummy placebo) (n = 33). |
| Group M: Intravenous Meperidine | Active comparator | Drug: Meperidine, Drug: Normal Saline 0.9%Participants receive 2 mL normal saline 0.9% intranasally 30 minutes before induction of spinal anesthesia (double-dummy placebo), along with an intravenous bolus of meperidine 0.5 mg/kg diluted to 10 mL normal saline immediately before spinal injection (n = 33). |
| Group C: Placebo Control | Placebo comparator | Drug: Normal Saline 0.9%Participants receive 2 mL normal saline 0.9% intranasally 30 minutes before induction of spinal anesthesia, along with an intravenous bolus of 10 mL normal saline 0.9% immediately before spinal injection (n = 33). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients aged 18 to 40 years.
- American Society of Anesthesiologists (ASA) physical status II.
- Term singleton pregnancy.
- Scheduled for elective cesarean section under spinal anesthesia.
Key exclusion criteria (9 listed)
- Refusal to participate.
- Contraindications to spinal anesthesia.
- Nasal pathology preventing intranasal drug administration.
- Known allergy or hypersensitivity to any study medication (dexmedetomidine, meperidine, or bupivacaine).
- Significant cardiac disease.
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 |
|---|---|---|
| DexmedetomidineAdministered intranasally at a dose of 1 mcg/kg diluted in 2 mL normal saline 0.9% using a sterile dropper, instilled slowly into each nostril 30 minutes before induction of spinal anesthesia in the pre-anesthesia room. | Drug | Group D: Intranasal Dexmedetomidine |
| MeperidineAdministered as an intravenous bolus at a dose of 0.5 mg/kg diluted to a total volume of 10 mL normal saline 0.9% immediately before the induction of spinal anesthesia. | Drug | Group M: Intravenous Meperidine |
| Normal Saline 0.9%Administered as an identical matching placebo within the double-dummy design: 2 mL intranasally (30 minutes prior to spinal anesthesia) and/or 10 mL as an intravenous bolus (immediately before spinal induction). | Drug | Group C: Placebo Control, Group D: Intranasal Dexmedetomidine, Group M: Intravenous Meperidine |
Primary outcome
Number of Participants With Intraoperative Shivering
Time frame: Through completion of surgery, up to 2 hours
Participants will be assessed for the occurrence of intraoperative shivering using a 5-point scale: Grade 0 = no shivering; Grade 1 = piloerection, peripheral vasoconstriction, or cyanosis; Grade 2 = visible muscle activity confined to one muscle group; Grade 3 = visible muscle activity involving more than one muscle group; Grade 4 = gross muscle activity involving the whole body (scores range from 0 to 4, where 0 indicates no shivering and 4 indicates severe whole-body shivering). Shivering is defined as the occurrence of Grade 1 or higher at any time during the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Meperidine and Normal Saline 0.9% in people with Shivering and Hypothermia, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of Participants With Intraoperative Shivering (time frame: Through completion of surgery, up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2026.