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NCT Number: NCT06942000

Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS.

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

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine, Al-Azhar University, Assiut, Egypt, Asyut, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dexmedetomidine 3mcg group

Drug

3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.

dexmedetomidine 5mcg

Drug

5mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.

preservative-free 0.9% saline.

Drug

(0.5 ml) preservative-free 0.9% saline

Primary outcomes

  1. efficacy on the incidence and severity of shivering associated with spinal anesthesia.

    Time frame: Shivering will be measured at the following time points: (Immediately after spinal anesthesia, and at 5, 10, 15, 20, 30, 40, 50, 60 and 90 minutes later

    evaluate the effect of intrathecal dexmedetomidine, administered as an adjunct to hyperbaric bupivacaine for Cesarean delivery, on the incidence and severity of shivering associated with spinal anesthesia.

Secondary outcomes

  1. incidence of adverse effects

    Time frame: Immediately after spinal anesthesia, and within 90 minutes later

    the incidence of adverse effects, including nausea, vomiting, bradycardia, hypotension and sedation.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed A. Mahmoud, MD

CONTACT

[email protected]

01002538320 ext. 002

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Efficacy of Dexmedetomidine as Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post-spinal Shivering in Pregnant Women Undergoing Cesarean Section.

Acronym: DEX

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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