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Completed

NCT Number: NCT02365857

Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Dexmedetomidine & Bupivacaine.

Drug

Intrathecal injection of Dexmedetomidine & Bupivacaine.

Bupivacaine Only.

Drug

Intrathecal injection of Bupivacaine only.

Primary outcomes

  1. The time to two sensory block segment regression.

    Time frame: 70 min

    Define the start of regression of the level of sensory block

Secondary outcomes

  1. The peak sensory level of the block.

    Time frame: 10 min

    By Pin Prick testing.

  2. Time from intrathecal injection to peak sensory block level.

    Time frame: 10 min

    Define the speed of onset of the block.

  3. Time to S1 level sensory regression.

    Time frame: 70 min

    Define duration of the block.

  4. Degree of motor block.

    Time frame: 24 h

    By Modified Bromage Score.

  5. Intraoperative hemodynamic variables.

    Time frame: 24 h

    Detect frequency of side effects

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

    Time frame: 24 h

    Detect frequency of side effects

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

    Time frame: 24 h

    Detect frequency of side effects

  8. Oxygen saturation (the need for O2 supplementation)

    Time frame: 24 h

    Detect frequency of side effects

  9. Intraoperative analgesic supplementation

    Time frame: 70 min

    Define quality of the block

  10. Time to first postoperative rescue analgesic request

    Time frame: 24 h

    Define duration of analgesia by the block

  11. Postoperative pain scores for 24 hours

    Time frame: 24 h

    Define duration of analgesia by the block

  12. Frequency of administration of postoperative analgesics

    Time frame: 24 h

    Define duration of analgesia by the block

  13. Intraoperative sedation scores

    Time frame: 24 h

    Detect frequency of side effects

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

    Time frame: 24 h

    Detect frequency of side effects

  15. New born Apgar Score

    Time frame: 5 min

    Detect any effects on the new born at different dose levels

  16. Duration of motor block.

    Time frame: 24 h

    By Modified Bromage Score.

  17. Early postoperative hemodynamic variables.

    Time frame: 24 h

    Detect frequency of side effects

  18. Total dose of postoperative analgesics

    Time frame: 24 h

    Define duration of analgesia by the block

  19. Postoperative sedation scores

    Time frame: 24 h

    Detect frequency of side effects

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 19, 2015
Registry last updated
Feb 2, 2016

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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