Postoperative ShiveringNCT05952752
Dexemedetomidine on Shivering Cesarean Section Under Spinal Anesthesia A Randomized Clinical Trial
A study testing giving dexemedetomidine 12 microgram Iv dripping and Dexamethsone IV in people with Postoperative Shivering, run by Assiut University at 1 site in Egypt.
Trial summary
Participants will examine dexemedetomidine versus dexamethasone on postoperative shivering after spinal anesthesia for caesarean section Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Postoperative Shivering
- What is being tested?
- giving dexemedetomidine 12 microgram Iv dripping and Dexamethsone IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 382 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2023to 1 Oct 2023
- 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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female
- Pregnant full term
- Undergoing Cesarean section
- Spinal anesthesia
Who cannot join
- Patient refusal
- General anesthesia
- Contraindications for spinal anesthesia
- Obstetric hemorrhagic complications as placenta accreta, previa, concealed hemorrhage
- Hysterectomy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university faculty of medicine
Asyut, Asyut Governorate, 71515
About this study
Official title: Effect of Dexamethasone Versus Dexmedetomidine on Postoperative Shivering After Cesarean Section Under Spinal Anesthesia
Participants will examine dexemedetomidine versus dexamethasone on postoperative shivering after spinal anesthesia for caesarean section
Read the detailed description
Patients and Methods Setting and ethics and trial registration The present randomized clinical study is planned to be conducted at Gynecology and Obstetrics Department, Assiut University Hospitals in the time from February through March, 2023. The study protocol will be approved by the independent institutional review board and all participants with provide informed consent prior to enrollment. The study will be registered at clinicaltrials.gov before recruitment of the first patient. Sample size calculation To detect a 20 % of differences between shivering scores in the studies groups, the sample size was calculated using a study power of 95.0 % and two-sided significance level of 5.0 % with 1:1 ratio. The estimated sample size for each group was 164 patients. We added 10 % of patients as expected dropout rate. So, the final sample size will be 191 patients per group. Sample size was calculated using G Power 3.1.6.9 (Kiel University, Germany).
Patient recruitment The present study will include American Society of Anesthesiology (ASA) I-II women scheduled for elective CS under intrathecal anesthesia. Patients will be excluded if they had local infection, bleeding disorder or known allergy to any of the study medications.
Randomization, blinding and allocation Patients in each study category will be equally and randomly assigned to receive either DEXA or DEXM using computer generated random tables and sealed envelopes. Independent researchers who aren't aware of the scope of the study will be assigned to assess and report patient outcome. Used medications will be prepared in similar packages to secure adequate blinding.
Preoperative preparation, monitoring and anesthesia All patients will be instructed, prepared and monitored according the standard guidelines.
Preoperative medications will include IV granisetron 1gm and ranitidine 50mg. Spinal anesthesia will be accomplished using 10-12 mg of 0.5% hyperbaric bupivacaine. When adequate level of anesthesia is guaranteed, CS is started under appropriate hemodynamic monitoring. Once the baby is delivered, 10 IV units of oxytocin will be administered.
Study interventions Patients in the studied groups will receive either or intravenous DEXM 10 µg (Sween et al., 2021) or IV infusion of DEXA 8 mg (Esmat et al., 2021). Outcome assessment The primary outcome of the present study is the incidence of clinically significant postoperative shivering (Grade 2/3) assessed by 4-point scale (Badjatia et al., 2008) as follows:
- None (Grade 0): no shivering noted on palpation of the masseter, neck, or chest wall
- Mild (Grade 1): shivering localized to the neck and/ or thorax only
- Moderate (Grade 2): shivering involved gross movement of the upper extremities (in addition to neck and thorax)
- Severe (Grade 3): shivering involved gross movements of the trunk and upper and lower extremities Secondary outcome measures will be postoperative pain, hypotension, sedation grade, patient satisfaction, time to sensory and motor onset and time to use of first rescue analgesia.
Statistical analysis All reported data will be recorded and statistically analyzed using appropriate statistical tests.
- Conditions
- Postoperative Shivering
- Being tested
- giving dexemedetomidine 12 microgram Iv dripping, Dexamethsone IV
- Keywords
- Dexmedetomidine, Dexamethasone, Postoperative shivering, Shivering, Postoperative analgesia, PONV
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
giving dexemedetomidine 12 microgram Iv drippingOther
Also called Dexemedetomidine
Patients in the studied groups will receive either or intravenous Dexemedetomidine 12 µg
Dexamethsone IVOther
Also called Dexamethasone
4 mg IV dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Dexamethsone | Placebo comparator | 4 mg will be given for this group IV Receives: Other: Dexamethsone IV |
| Dexemedetomidine | Experimental | 12 ug will be given IV infusion for this group Receives: Other: giving dexemedetomidine 12 microgram Iv dripping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of postoperative shivering according to bedside shivering assessment scale
- grade I: no shivering (score 0)
- Grade II: localized to the neck or thorax mainly (score 1)
- Grade III: moderate shivering including the gross length of upper extremeties(score2)
- Grade IV:severe shivering including the gross movement of the trunk, upper and lower extremities( score 3)
Measured: till end of spinal anesthesia up to 6 hours
Secondary outcomes (1)
postoperative analgesia according to numerical rating scale( NRS)
NRS score assessment in combination to time to first rescue of analgesia including score 1 with the least pain experienced in life and score 10 as the most painful experienced pain in life then the pain grading is in between
Measured: 6 hours after induction of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start20 Jul 2023
- Primary completion25 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The estimated sample size for each group was 164 patients. We added 10 % of patients as expected dropout rate. So, the final sample size will be 191 patients per group. Sample size was calculated using G Power 3.1.6.9 (Kiel University, Germany). The present study will include American Society of Anesthesiology (ASA) I-II women scheduled for elective CS under intrathecal anesthesia. All patients will be instructed, prepared and monitored according the standard guidelines. Preoperative medications will include IV granisetron 1gm and ranitidine 50mg. Spinal anesthesia will be accomplished using 10-12 mg of 0.5% hyperbaric bupivacaine. When adequate level of anesthesia is guaranteed, CS is started under appropriate hemodynamic monitoring. Once the baby is delivered, 10 IV units of oxytocin will be administered. Patients in the studied groups will receive either or intravenous DEXM 10 µg (Sween et al., 2021) or IV infusion of DEXA 8 mg (Esmat et al., 2021).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Abd El-Khalek Mohammed Glala, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952752
- Sponsor's protocol ID
- dexemedetomidine on shivering
- Status last verified
- Dec 2025
- First submitted
- 2 Jul 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexamethasone Versus Dexmedetomidine on Postoperative Shivering After Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05952752
- Acronym / sponsor ID
- dexemedetomidine on shivering
- Conditions
- Postoperative Shivering
- Keywords
- Dexmedetomidine, Dexamethasone, Postoperative shivering, Shivering, Postoperative analgesia, PONV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 19 Jul 2023 (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.
Participants will examine dexemedetomidine versus dexamethasone on postoperative shivering after spinal anesthesia for caesarean section
Detailed description
Patients and Methods Setting and ethics and trial registration The present randomized clinical study is planned to be conducted at Gynecology and Obstetrics Department, Assiut University Hospitals in the time from February through March, 2023. The study protocol will be approved by the independent institutional review board and all participants with provide informed consent prior to enrollment. The study will be registered at clinicaltrials.gov before recruitment of the first patient. Sample size calculation To detect a 20 % of differences between shivering scores in the studies groups, the sample size was calculated using a study power of 95.0 % and two-sided significance level of 5.0 % with 1:1 ratio. The estimated sample size for each group was 164 patients. We added 10 % of patients as expected dropout rate. So, the final sample size will be 191 patients per group. Sample size was calculated using G Power 3.1.6.9 (Kiel University, Germany).
Patient recruitment The present study will include American Society of Anesthesiology (ASA) I-II women scheduled for elective CS under intrathecal anesthesia. Patients will be excluded if they had local infection, bleeding disorder or known allergy to any of the study medications.
Randomization, blinding and allocation Patients in each study category will be equally and randomly assigned to receive either DEXA or DEXM using computer generated random tables and sealed envelopes. Independent researchers who aren't aware of the scope of the study will be assigned to assess and report patient outcome. Used medications will be prepared in similar packages to secure adequate blinding.
Preoperative preparation, monitoring and anesthesia All patients will be instructed, prepared and monitored according the standard guidelines.
Preoperative medications will include IV granisetron 1gm and ranitidine 50mg. Spinal anesthesia will be accomplished using 10-12 mg of 0.5% hyperbaric bupivacaine. When adequate level of anesthesia is guaranteed, CS is started under appropriate hemodynamic monitoring. Once the baby is delivered, 10 IV units of oxytocin will be administered.
Study interventions Patients in the studied groups will receive either or intravenous DEXM 10 µg (Sween et al., 2021) or IV infusion of DEXA 8 mg (Esmat et al., 2021). Outcome assessment The primary outcome of the present study is the incidence of clinically significant postoperative shivering (Grade 2/3) assessed by 4-point scale (Badjatia et al., 2008) as follows:
- None (Grade 0): no shivering noted on palpation of the masseter, neck, or chest wall
- Mild (Grade 1): shivering localized to the neck and/ or thorax only
- Moderate (Grade 2): shivering involved gross movement of the upper extremities (in addition to neck and thorax)
- Severe (Grade 3): shivering involved gross movements of the trunk and upper and lower extremities Secondary outcome measures will be postoperative pain, hypotension, sedation grade, patient satisfaction, time to sensory and motor onset and time to use of first rescue analgesia.
Statistical analysis All reported data will be recorded and statistically analyzed using appropriate statistical tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The estimated sample size for each group was 164 patients. We added 10 % of patients as expected dropout rate. So, the final sample size will be 191 patients per group. Sample size was calculated using G Power 3.1.6.9 (Kiel University, Germany). The present study will include American Society of Anesthesiology (ASA) I-II women scheduled for elective CS under intrathecal anesthesia. All patients will be instructed, prepared and monitored according the standard guidelines. Preoperative medications will include IV granisetron 1gm and ranitidine 50mg. Spinal anesthesia will be accomplished using 10-12 mg of 0.5% hyperbaric bupivacaine. When adequate level of anesthesia is guaranteed, CS is started under appropriate hemodynamic monitoring. Once the baby is delivered, 10 IV units of oxytocin will be administered. Patients in the studied groups will receive either or intravenous DEXM 10 µg (Sween et al., 2021) or IV infusion of DEXA 8 mg (Esmat et al., 2021).
| Arm | Type | Receives |
|---|---|---|
| Dexamethsone | Placebo comparator | Other: Dexamethsone IV4 mg will be given for this group IV |
| Dexemedetomidine | Experimental | Other: giving dexemedetomidine 12 microgram Iv dripping12 ug will be given IV infusion for this group |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female
- Pregnant full term
- Undergoing Cesarean section
- Spinal anesthesia
Key exclusion criteria (5 listed)
- Patient refusal
- General anesthesia
- Contraindications for spinal anesthesia
- Obstetric hemorrhagic complications as placenta accreta, previa, concealed hemorrhage
- Hysterectomy
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 |
|---|---|---|
| giving dexemedetomidine 12 microgram Iv drippingAlso: DexemedetomidinePatients in the studied groups will receive either or intravenous Dexemedetomidine 12 µg | Other | Dexemedetomidine |
| Dexamethsone IVAlso: Dexamethasone4 mg IV dexamethasone | Other | Dexamethsone |
Primary outcome
Prevention of postoperative shivering according to bedside shivering assessment scale
Time frame: till end of spinal anesthesia up to 6 hours
* grade I: no shivering (score 0) * Grade II: localized to the neck or thorax mainly (score 1) * Grade III: moderate shivering including the gross length of upper extremeties(score2) * Grade IV:severe shivering including the gross movement of the trunk, upper and lower extremities( score 3)
1 secondary outcome
postoperative analgesia according to numerical rating scale( NRS)
Time frame: 6 hours after induction of spinal anesthesia
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 26 Dec 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 giving dexemedetomidine 12 microgram Iv dripping and Dexamethsone IV in people with Postoperative Shivering, run by Assiut University 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 4 inclusion and 5 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 26 Dec 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. 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.
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?
Prevention of postoperative shivering according to bedside shivering assessment scale (time frame: till end of spinal anesthesia up to 6 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 26 Dec 2025.