---
title: Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section
nct_id: NCT06318546
overall_status: COMPLETED
phase: PHASE1
sponsor: Ain Shams University
study_type: INTERVENTIONAL
primary_condition: Post Spinal Shivering
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06318546.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06318546"
ct_last_update_post_date: 2024-11-05
last_seen_at: "2026-05-12T07:01:07.514Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Dexmedetomidine in Spinal Anesthesia Decreasing Post Spinal Shivering in Caesarean Section

**Official Title:** Efficacy of Dexmedetomidine As Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post Spinal Shivering in Parturients Undergoing Caesarean Section

**NCT ID:** [NCT06318546](https://clinicaltrials.gov/study/NCT06318546)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 130
- **Lead Sponsor:** Ain Shams University
- **Conditions:** Post Spinal Shivering
- **Start Date:** 2024-04-01
- **Completion Date:** 2024-08-31
- **CT.gov Last Update:** 2024-11-05

## Brief Summary

The investigators will test the effects of intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine and it's direct effect in decreasing incidence of post spinal shivering in Parturients Undergoing Caesarean section

## Detailed Description

A.Preoperative settings:

All patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. An informed written consent will be taken from every patient just before the surgery.

B.Intraoperative and postoperative settings:

On arrival to the operating room, baseline parameters such as ECG, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. Intravenous line will be inserted and IV Ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\\kg.

For each group, patients will be put in sitting position, the procedure will be performed under complete aseptic precautions, local anaesthesia will be administered by infiltration of the skin and subcutaneous tissues with 3-5 ml lidocaine 1% at L3-L4 and A 25-G needle will be used.

Both groups will be given 2.2ml {11-12 mg} hyperbaric Bupivacaine hydrochloride 0.5%

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 35 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* • ASA I or ASA II patients Scheduled for CS under spinal anaesthesia.

  * Age 20-35 years.
  * Height ≤165 cm.
  * BMI ≤40.
  * Procedure duration ≤ 90 minutes.

Exclusion Criteria:

* • Patients with known neurologic and psychiatric illness.

  * Contraindications for spinal anaesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia.
  * Spine abnormalities.
  * Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
  * Allergy to any of the drugs used in the study.
  * Toxemia of pregnancy or hypertension with pregnancy.
```

## Arms

- **Control** (ACTIVE_COMPARATOR) — This group will undergo spinal anesthesia using fentanyl (50 microgram) as adjuvant to intrathecal bupivacaine
- **Dexmedetomidine** (ACTIVE_COMPARATOR) — This group will undergo spinal anesthesia using dexmedetomidine (10mg) as adjuvant to intrathecal bupivacaine

## Interventions

- **Dexmedetomidine Injection [Precedex],,,** (DRUG) — patients will receive 0.5ml (10 µg) Dexmedetomidine as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%
- **Fentanyl** (DRUG) — will be given 0.5 ml of one ampoule (2ml) of 100µg fentanyl (Fentanyl Hameln® 0.1mg/2ml - Sunny pharm) equivalent to 25 µg fentanyl as an adjuvant to 2.2ml hyperbaric Bupivacaine hydrochloride 0.5%

## Primary Outcomes

- **Post spinal shivering** _(time frame: From injection to 3 hours post operative)_ — will be observed following spinal anaesthesia and thereafter for 3 hours. It will be graded by a blinded observer during the intraoperative and postoperative period using the scale validated by Crossley and Mahajan \[0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 = shivering involving the whole body\]. Grades 3, and 4 shivering for at least 3 min will be considered positive, and maximum shivering will be considered if generalized shivering interfering with ECG monitoring or ability of the mother to hold the baby. Positive shivering or lower grade shivering will be treated with an IV bolus of meperidine (0.5 mg/kg)

## Locations (1)

- Ain Shams University, Cairo, Egypt

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ain shams university|cairo||egypt` — added _(2026-05-12)_

---

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