Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section

Anesthesia, Spinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02365857
• Other study ID #: thecaldex
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2015
• Last updated: January 30, 2016
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Anesthesia, Spinal

Intervention

Drug:
• Dexmedetomidine & Bupivacaine.
Intrathecal injection of Dexmedetomidine & Bupivacaine.
• Bupivacaine Only.
Intrathecal injection of Bupivacaine only.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to two sensory block segment regression.	Define the start of regression of the level of sensory block	70 min	No
Secondary	The peak sensory level of the block.	By Pin Prick testing.	10 min	No
Secondary	Time from intrathecal injection to peak sensory block level.	Define the speed of onset of the block.	10 min	No
Secondary	Time to S1 level sensory regression.	Define duration of the block.	70 min	No
Secondary	Degree of motor block.	By Modified Bromage Score.	24 h	No
Secondary	Intraoperative hemodynamic variables.	Detect frequency of side effects	24 h	No
Secondary	The total dose of ephedrine/atropine required to maintain hemodynamic stability.	Detect frequency of side effects	24 h	No
Secondary	The amount of lactated Ringer's solution required intraoperatively to maintain normal Blood pressure range	Detect frequency of side effects	24 h	No
Secondary	Oxygen saturation (the need for O2 supplementation)	Detect frequency of side effects	24 h	No
Secondary	Intraoperative analgesic supplementation	Define quality of the block	70 min	No
Secondary	Time to first postoperative rescue analgesic request	Define duration of analgesia by the block	24 h	No
Secondary	Postoperative pain scores for 24 hours	Define duration of analgesia by the block	24 h	No
Secondary	Frequency of administration of postoperative analgesics	Define duration of analgesia by the block	24 h	No
Secondary	Intraoperative sedation scores	Detect frequency of side effects	24 h	No
Secondary	Incidence of side effects (nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation)	Detect frequency of side effects	24 h	No
Secondary	New born Apgar Score	Detect any effects on the new born at different dose levels	5 min	No
Secondary	Duration of motor block.	By Modified Bromage Score.	24 h	No
Secondary	Early postoperative hemodynamic variables.	Detect frequency of side effects	24 h	No
Secondary	Total dose of postoperative analgesics	Define duration of analgesia by the block	24 h	No
Secondary	Postoperative sedation scores	Detect frequency of side effects	24 h	No