Dexemedetomidine on Shivering Cesarean Section Under Spinal Anesthesia A Randomized Clinical Trial

NCT ID: NCT05952752

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2023-10-01

Brief Summary

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:

1. None (Grade 0): no shivering noted on palpation of the masseter, neck, or chest wall

2. Mild (Grade 1): shivering localized to the neck and/ or thorax only

3. Moderate (Grade 2): shivering involved gross movement of the upper extremities (in addition to neck and thorax)

4. 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

Keywords

Dexmedetomidine; Dexamethasone; Postoperative shivering; Shivering; Postoperative analgesia; PONV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Dexamethsone

4 mg will be given for this group IV

Group Type: PLACEBO_COMPARATOR

Dexamethsone IV

Intervention Type: OTHER

4 mg IV dexamethasone

Dexemedetomidine

12 ug will be given IV infusion for this group

Group Type: EXPERIMENTAL

giving dexemedetomidine 12 microgram Iv dripping

Intervention Type: OTHER

Patients in the studied groups will receive either or intravenous Dexemedetomidine 12 µg

Interventions

giving dexemedetomidine 12 microgram Iv dripping

Patients in the studied groups will receive either or intravenous Dexemedetomidine 12 µg

Intervention Type: OTHER

Dexamethsone IV

4 mg IV dexamethasone

Intervention Type: OTHER

Other Intervention Names

Dexemedetomidine; Dexamethasone

Eligibility Criteria

Inclusion Criteria

• Female
• Pregnant full term
• Undergoing Cesarean section
• Spinal anesthesia

Exclusion Criteria

• Patient refusal
• General anesthesia
• Contraindications for spinal anesthesia
• Obstetric hemorrhagic complications as placenta accreta, previa, concealed hemorrhage
• Hysterectomy

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Abd El-Khalek Mohammed Glala

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut university faculty of medicine

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Other Identifiers

dexemedetomidine on shivering

Identifier Type: -

Identifier Source: org_study_id