Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section

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

Study Overview

• Status: Completed
• Conditions: Anesthesia, Spinal
• Intervention / Treatment: Drug: Dexmedetomidine & Bupivacaine.; Drug: Bupivacaine Only.

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: Dexmedetomidine & Bupivacaine.; Intrathecal injection of Dexmedetomidine & Bupivacaine.
ACTIVE_COMPARATOR: 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.	Drug: Dexmedetomidine & Bupivacaine.; Intrathecal injection of Dexmedetomidine & Bupivacaine.
ACTIVE_COMPARATOR: 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.	Drug: Dexmedetomidine & Bupivacaine.; Intrathecal injection of Dexmedetomidine & Bupivacaine.
ACTIVE_COMPARATOR: 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.	Drug: Bupivacaine Only.; Intrathecal injection of Bupivacaine only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to two sensory block segment regression.	Define the start of regression of the level of sensory block	70 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The peak sensory level of the block.	By Pin Prick testing.	10 min
Time from intrathecal injection to peak sensory block level.	Define the speed of onset of the block.	10 min
Time to S1 level sensory regression.	Define duration of the block.	70 min
Degree of motor block.	By Modified Bromage Score.	24 h
Intraoperative hemodynamic variables.	Detect frequency of side effects	24 h
The total dose of ephedrine/atropine required to maintain hemodynamic stability.	Detect frequency of side effects	24 h
The amount of lactated Ringer's solution required intraoperatively to maintain normal Blood pressure range	Detect frequency of side effects	24 h
Oxygen saturation (the need for O2 supplementation)	Detect frequency of side effects	24 h
Intraoperative analgesic supplementation	Define quality of the block	70 min
Time to first postoperative rescue analgesic request	Define duration of analgesia by the block	24 h
Postoperative pain scores for 24 hours	Define duration of analgesia by the block	24 h
Frequency of administration of postoperative analgesics	Define duration of analgesia by the block	24 h
Intraoperative sedation scores	Detect frequency of side effects	24 h
Incidence of side effects (nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation)	Detect frequency of side effects	24 h
New born Apgar Score	Detect any effects on the new born at different dose levels	5 min
Duration of motor block.	By Modified Bromage Score.	24 h
Early postoperative hemodynamic variables.	Detect frequency of side effects	24 h
Total dose of postoperative analgesics	Define duration of analgesia by the block	24 h
Postoperative sedation scores	Detect frequency of side effects	24 h

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (ESTIMATE): February 19, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 2, 2016
• Last Update Submitted That Met QC Criteria: January 30, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: spinal anesthesia; Dexmedetomidine; caesarian section
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: thecaldex