Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section

NCT ID: NCT02365857

Last Updated: 2016-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-10-31

Brief 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.

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.

Conditions

Anesthesia, Spinal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

DEX-5

Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 5 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine & Bupivacaine.

Intervention Type: DRUG

Intrathecal injection of Dexmedetomidine \& Bupivacaine.

DEX-10

Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 10 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine & Bupivacaine.

Intervention Type: DRUG

Intrathecal injection of Dexmedetomidine \& Bupivacaine.

DEX-15

Dexmedetomidine \& Bupivacaine. Patients will receive intrathecal 12.5 mg isobaric bupivacaine and 15 μg Dexmedetomidine using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine & Bupivacaine.

Intervention Type: DRUG

Intrathecal injection of Dexmedetomidine \& Bupivacaine.

Control

Bupivacaine Only. Patients will receive intrathecal 12.5 mg isobaric bupivacaine only using a total volume of injectate of 2.5 ml, and intrathecal injections will be given over approximately 10 to 15 seconds.

Group Type: ACTIVE_COMPARATOR

Bupivacaine Only.

Intervention Type: DRUG

Intrathecal injection of Bupivacaine only.

Interventions

Dexmedetomidine & Bupivacaine.

Intrathecal injection of Dexmedetomidine \& Bupivacaine.

Intervention Type: DRUG

Bupivacaine Only.

Intrathecal injection of Bupivacaine only.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Professor Mohamed Abdulatif Mohamed

Abdulatif M.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

thecaldex

Identifier Type: -

Identifier Source: org_study_id