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Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section

Information source: Cairo University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anesthesia, Spinal

Intervention: Dexmedetomidine & Bupivacaine. (Drug); Bupivacaine Only. (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Cairo University


A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and side effect profile of different dose levels of Dexmedetomidine added to subarachnoid bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal anesthesia. The investigators ultimate goal is to find out the least effective dose which will be associated with minimal or no side effects. The primary outcome will be the time to two sensory block segment regression.

Clinical Details

Official title: Effects of Intrathecal Dexmedetomidine on the Perioperative Clinical Profile of Bupivacaine-induced Spinal Anesthesia for Cesarean Section

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The time to two sensory block segment regression.

Secondary outcome:

The peak sensory level of the block.

Time from intrathecal injection to peak sensory block level.

Time to S1 level sensory regression.

Degree of motor block.

Intraoperative hemodynamic variables.

The total dose of ephedrine/atropine required to maintain hemodynamic stability.

The amount of lactated Ringer's solution required intraoperatively to maintain normal Blood pressure range

Oxygen saturation (the need for O2 supplementation)

Intraoperative analgesic supplementation

Time to first postoperative rescue analgesic request

Postoperative pain scores for 24 hours

Frequency of administration of postoperative analgesics

Intraoperative sedation scores

Incidence of side effects (nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation)

New born Apgar Score

Duration of motor block.

Early postoperative hemodynamic variables.

Total dose of postoperative analgesics

Postoperative sedation scores

Detailed description: Alpha 2-agonists are non-opioid adjuvants with a significant role in extending the analgesic duration of subarachnoid block. When clonidine or Dexmedetomidine was added to intrathecal local anesthetics, the regression of sensory and motor blocks increased dose-dependently. Further, a recent meta-analysis including seven randomized controlled studies reported an increase in the duration of analgesia and reduced morphine requirement after the concomitant subarachnoid administration of clonidine. Animal studies demonstrated that Dexmedetomidine added to bupivacaine significantly enhanced the duration of sensory and motor blockade of sciatic nerve block. Histo-pathological examination proved that all of the nerves analyzed had normal axons and myelin at 24 h and 14 days after the peri-neural administration of Dexmedetomidine. Several clinical studies confirmed the analgesic potentials and safe neurological outcome of neuraxially administered Dexmedetomidine in the non-obstetric settings while intrathecal clonidine proved to be a useful analgesic adjunct for spinal anesthesia in patients undergoing cesarean section. But to the best of the investigator knowledge the effects of intrathecal Dexmedetomidine on the perioperative clinical profile of bupivacaine-induced spinal anesthesia were not studied before in the obstetric patient population.


Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.


Inclusion Criteria:

- Full-term pregnant women.

- Elective cesarean section using spinal anesthesia.

- Singleton gestation.

- American Society of Anesthesiologists (ASA) physical status classes I and II.

Exclusion Criteria:

- Preterm pregnancy (<37 wks gestation).

- Multiple gestation.

- Cardiovascular disease (e. g., preeclampsia, hypertension) and the use of

antihypertensive medication.

- Conditions that preclude spinal anesthesia.

- Failed spinal block and conversion to general anesthesia.

- A history of established chronic pain.

- Drug addiction.

- A psychiatric disorder.

- Inability to communicate effectively.

- Asthma and allergy to non-steroidal anti-inflammatory drugs.

Locations and Contacts

Additional Information

Starting date: December 2014
Last updated: February 11, 2015

Page last updated: August 23, 2015

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