Clinical trial NCT03775655: Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section
Official title: Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cesarean Section
Spinal Anesthesia
Dexmedetomidine
Keywords: Cesarean Section
Intrathecal Dexmedetomidine
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Density of motor and sensory blockade
timeFrame: Intraoperative
measure: Haemodynamic stability and total doses of IV fluids and vasopressors
timeFrame: Intraoperative
measure: Time to first postoperative rescue analgesic request
timeFrame: 24 hour
Secondary outcomes:
measure: The intraoperative patient and surgeon satisfaction (successful delivery)
timeFrame: Intraoperative
measure: The peak sensory level of block
timeFrame: Intraoperative
measure: Time from intrathecal injection to peak sensory block level
timeFrame: Intraoperative
measure: The time to two sensory block segment regression
timeFrame: Intraoperative and 24 hour
measure: Degree and duration of motor block
timeFrame: Intraoperative and 24 hour
measure: Intraoperative analgesic supplementation during operation
timeFrame: Intraoperative
measure: Postoperative pain scores for 24 hours
timeFrame: 24 hour
measure: Frequency and total dose of postoperative analgesics
timeFrame: 24 hour
measure: Intraoperative and postoperative sedation scores
timeFrame: Intraoperative and 24 hour
measure: Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation.
timeFrame: Intraoperative and 24 hour
measure: Hospital in stay
timeFrame: 24 hour
measure: Time to S1 level sensory regression
timeFrame: Intraoperative and 24 hour
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University Hospitals
state: Menoufia
Study officials:
affiliation: Faculty of Medicine - Menoufia University
name: Mamdoh Lotfy, Prof. Dr.
role: STUDY_CHAIR
affiliation: Faculty of Medicine - Menoufia University
name: Safaa M Helal, Prof. Dr.
role: STUDY_CHAIR
affiliation: Faculty of Medicine - Menoufia University
name: Wesameldin A Soltan, Dr.
role: STUDY_DIRECTOR
References: