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Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section

Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section: Randomized Controlled Trial

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03775655
Enrollment
40
Registered
2018-12-14
Start date
2018-09-01
Completion date
2019-01-10
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Dexmedetomidine, Spinal Anesthesia

Keywords

Cesarean Section, Intrathecal Dexmedetomidine

Brief summary

The aim of this study is to evaluate the effectiveness of low dose scheme with dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical conditions, best post-operative pain free experience, and more stable hemodynamic.

Interventions

DRUGDexmedetomidine

10μg dexmedetomidine will be added to the injectate to be injected intrathecally

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Full-term pregnant women * Singleton gestation * American Society of Anaesthesiologists (ASA) physical status classes II and I

Exclusion criteria

* Preterm pregnancy (\<37 wks. gestation) * Multiple gestation * Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medications * Asthma and allergy to non-steroidal anti-inflammatory drugs * Conditions that prevent spinal anaesthesia * Failed spinal block and conversion to general anaesthesia * A history of established chronic pain * Drug addiction * A psychiatric disorder * Inability to communicate effectively

Design outcomes

Primary

MeasureTime frame
Density of motor and sensory blockadeIntraoperative
Haemodynamic stability and total doses of IV fluids and vasopressorsIntraoperative
Time to first postoperative rescue analgesic request24 hour

Secondary

MeasureTime frame
The time to two sensory block segment regressionIntraoperative and 24 hour
Degree and duration of motor blockIntraoperative and 24 hour
Intraoperative analgesic supplementation during operationIntraoperative
Postoperative pain scores for 24 hours24 hour
The intraoperative patient and surgeon satisfaction (successful delivery)Intraoperative
Intraoperative and postoperative sedation scoresIntraoperative and 24 hour
Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation.Intraoperative and 24 hour
Hospital in stay24 hour
Time to S1 level sensory regressionIntraoperative and 24 hour
Frequency and total dose of postoperative analgesics24 hour
The peak sensory level of blockIntraoperative
Time from intrathecal injection to peak sensory block levelIntraoperative

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026