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

NCT05952752 | Completed DMC

• 1 other identifier: dexemedetomidine on shivering
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

Brief Summary

Participants will examine dexemedetomidine versus dexamethasone on postoperative shivering after spinal anesthesia for caesarean section

Conditions

Postoperative Shivering

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  till end of spinal anesthesia up to 6 hours

Secondary Outcomes (1)

• postoperative analgesia according to numerical rating scale( NRS)

  6 hours after induction of spinal anesthesia

Study Arms (2)

Dexamethsone

PLACEBO COMPARATOR

4 mg will be given for this group IV

Other: Dexamethsone IV

Dexemedetomidine

EXPERIMENTAL

12 ug will be given IV infusion for this group

Other: giving dexemedetomidine 12 microgram Iv dripping

Interventions

giving dexemedetomidine 12 microgram Iv dripping OTHER

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

Also known as: Dexemedetomidine

Dexemedetomidine

Dexamethsone IV OTHER

4 mg IV dexamethasone

Also known as: Dexamethasone

Dexamethsone

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university faculty of medicine

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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).

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: July 19, 2023
• Study Start: July 20, 2023
• Primary Completion: September 25, 2023
• Study Completion: October 1, 2023
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

EG (1)