NCT02365857

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

February 4, 2015

Last Update Submit

January 30, 2016

Conditions

Anesthesia, Spinal

Keywords

spinal anesthesiacaesarian sectionDexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • The time to two sensory block segment regression.

    Define the start of regression of the level of sensory block

    70 min

Secondary Outcomes (19)

  • The peak sensory level of the block.

    10 min

  • Time from intrathecal injection to peak sensory block level.

    10 min

  • Time to S1 level sensory regression.

    70 min

  • Degree of motor block.

    24 h

  • Intraoperative hemodynamic variables.

    24 h

  • +14 more secondary outcomes

Study Arms (4)

DEX-5

ACTIVE COMPARATOR

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.

DEX-10

ACTIVE COMPARATOR

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.

DEX-15

ACTIVE COMPARATOR

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.

Control

ACTIVE COMPARATOR

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.

Interventions

Dexmedetomidine & Bupivacaine.DRUG

Intrathecal injection of Dexmedetomidine \& Bupivacaine.

DEX-10DEX-15DEX-5
Bupivacaine Only.DRUG

Intrathecal injection of Bupivacaine only.

Control

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Full-term pregnant women.
  • Elective cesarean section using spinal anesthesia.
  • Singleton gestation.
  • American Society of Anesthesiologists (ASA) physical status classes I and II.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DexmedetomidineBupivacaine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Abdulatif M.

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 19, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

February 2, 2016

Record last verified: 2016-01