Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS.

Al-Azhar University

Status and phase: Not yet enrolling; Phase 3

Conditions: Post Spinal Anesthesia Shivering

Treatments: Drug: dexmedetomidine 3mcg group; Drug: preservative-free 0.9% saline.; Drug: dexmedetomidine 5mcg

Study type: Interventional

Funder types: Other

Identifiers

NCT06942000

MSC/AZAST/API029/2/239/1/2025.

Details and patient eligibility

About

This prospective, randomized, double-blind, placebo-controlled study to determine whether intrathecal dexmedetomidine, administered along with hyperbaric bupivacaine for covering Cesarean delivery decreases the incidence of shivering associated with spinal anesthesia

Full description

The study will be carried out at AL Azhar University Hospitals (Assiut) on 120 parturients belonging to ASA physical status I and II undergoing an elective cesarean delivery under spinal anesthesia procedure.

Sample size was determined by department of statistics of faculty of medicine, Al-Azhar university (Assiut).

Randomization, blinding and allocation concealment parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence

Enrollment: 40 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Full-term pregnant women undergoing elective cesarean section under spinal anesthesia.
• singleton pregnancy
• Age: 20 ~ 40 years;
• ASA physical status II ~ III;

Exclusion criteria

• parturient less than 20 years and more than 40 years.
• History of uncontrolled comorbidities, cardiac (e.g., pre-eclampsia and hypertension), respiratory, renal or hepatic disease.
• parturients who had allergy to any medication in the study.
• parturients with contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity)
• parturient who has history of alcohol intake.
• parturient received any medication likely to affect thermoregulation or Veno dilation.
• Refusing to sign informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 3 patient groups, including a placebo group

Group D3: (dexmedetomidine 3mcg group)

Active Comparator group

Description:

parturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine .

Treatment:

Drug: dexmedetomidine 3mcg group

Group D5: (dexmedetomidine 5mcg group)

Active Comparator group

Description:

parturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine .

Treatment:

Drug: dexmedetomidine 5mcg

Group C: (Control group)

Placebo Comparator group

Description:

parturients will receive spinal anesthesia consisting of 2 ml (10 mg) of 0.5% hyperbaric bupivacaine.

Treatment:

Drug: preservative-free 0.9% saline.