Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Anesthesia, Spinal

Treatments: Drug: Bupivacaine Only.; Drug: Dexmedetomidine & Bupivacaine.

Study type: Interventional

Funder types: Other

Identifiers

NCT02365857

thecaldex

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

DEX-5

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine & Bupivacaine.

DEX-10

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine & Bupivacaine.

DEX-15

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine & Bupivacaine.

Control

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine Only.