Intrathecal Dexmedetomidine to Decrease Postoperative Nausea and Vomiting and Shivering.

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Intrathecal Dexmedetomidine

Treatments: Drug: Dexmedetomidine Injection [Precedex]

Study type: Interventional

Funder types: Other

Identifiers

NCT05892705

FAMSU R 120 / 2021

Details and patient eligibility

About

Background: Highly selective α-2 agonist dexmedetomidine in increasingly used as an intrathecal adjuvant for caesarean section performed under subarachnoid block.

Aim of the Study: The aim of the study is to determine whether low dose dexmedetomidine added to local anesthetic for spinal anesthesia will attenuate perioperative nausea and vomiting and shivering in lower segment caesarean section (LSCS) with minimal hemodynamic instability or not.

Patients and Methods: Sixty parturients planned for elective CSs under spinal anesthesia were enrolled in this prospective controlled study and randomly divided into two equal groups. Spinal block was achieved with 10mg hyperbaric bupivacaine 0.5% plus 5µg dexmedetomidine (group D) (dexmedetomidine group) or 0.2 ml normal saline (group C) (control group). Hemodynamic parameters, incidence of nausea and vomiting and shivering were recorded.

Keywords: Dexmedetomidine, Cesarean Section, Bupivacaine, Spinal Anesthesia, Shivering, PONV

Enrollment: 60 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Medically free pregnant Female from 18 to 30 yrs old.
• Undergoing elective LSCS.
• Body mass index less than 40.
• Consenting for sub arachnoid anesthesia.
• Coagulation profile is within normal ranges.

Exclusion criteria

• Emergency LSCS.
• Patient refusal enrollment in the study.
• Allergy to the medications.
• Coagulopathy or anticoagulation drugs.
• Fetal or Maternal comorbidities.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups, including a placebo group

Study drug (dexmedetomidine intrathecal)

Active Comparator group

Description:

5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.

Treatment:

Drug: Dexmedetomidine Injection [Precedex]

Control (saline)

Placebo Comparator group

Description:

0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.

Treatment:

Drug: Dexmedetomidine Injection [Precedex]