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Clinical Trials/NCT06055101
NCT06055101
Completed
Not Applicable

Intrathecal Bupivacaine-Dexmedetomidine Compared to Intrathecal Bupivacaine-Neostigmine in Elective Caesarean Sections, Randomized Clinical Trial

Reham Ali Abdelhaleem Abdelrahman1 site in 1 country54 target enrollmentJanuary 3, 2019

Overview

Phase
Not Applicable
Intervention
DEXMEDETOMIDINE
Conditions
Anesthesia, Obstetric
Sponsor
Reham Ali Abdelhaleem Abdelrahman
Enrollment
54
Locations
1
Primary Endpoint
Time started from the end of intrathecal injection till achievement of a bilateral sensory block at T10
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Spinal anesthesia is an established technique used in obstetric surgeries, It provides adequate analgesia both intra and post-operative and also avoids complications associated with general anesthesia for mother and fetus. The quality of spinal anesthesia has been reported to be improved by using additives Dexmedetomidine is a highly selective α2-adrenoreceptor agonist that has been introduced to anesthesia. It produces dose-dependent sedation, anxiolysis, and analgesia without respiratory depression. Neostigmine is an anticholinesterase agent, which inhibits the hydrolysis of acetylcholine by competing with acetylcholine for attachment to acetyl cholinesterase; administration of Neostigmine through intrathecal route apparently activates the descending pain inhibitory system that relies on spinal cholinergic interneuron. Study conducted to evaluate whether neostigmine given by intrathecal route with 0.5% hyperbaric bupivacaine for spinal anesthesia can provide prolongation of sensory blockade duration as effective as dexmedetomidine given by the same route and in compination with same drug with lower cost, more stable hemodynamics and comparable side effects. After obtaining Institutional Ethics Committee approval and written informed consent,54 patients American Society of Anesthesiologist (ASA) physical status I and II were enrolled into the study and were randomlyassigned into 3 groups. Group 1were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (10 μg) DXM and 0.1 ml normal saline, Group 2 were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (50 μg) neostigmine and 0.1 ml normal saline and Group 3were received 10 mg (2ml) hyperbaric bupivacaine and 0.2 ml normal saline as control.

The investigators measured the time to reach T4 dermatome sensory block, peak sensory level, Time to reach Bromage 3 motor block, the regression time for sensory and motor block, also the investigators measured hemodynamic, sedation score, visual analogue score, any complications occurred and Apgar score for fetus during blockade and the investigators assessed the duration of pain relief .

Registry
clinicaltrials.gov
Start Date
January 3, 2019
End Date
April 4, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Reham Ali Abdelhaleem Abdelrahman
Responsible Party
Sponsor Investigator
Principal Investigator

Reham Ali Abdelhaleem Abdelrahman

Anesthesia lecturer M.D.

Cairo University

Eligibility Criteria

Inclusion Criteria

  • ASA physical status I and II patients
  • Age: 18 - 40 years
  • Height 150 - 170 cm
  • Weight 70 - 110 kg.

Exclusion Criteria

  • Patient refusal
  • Cardiac diseases as ( ischemic heart disease, severe valvular stenosis, pulmonary hypertension, uncontrolled arrhythmias )
  • Severe labile hypertension BP more than 160 / 100 )
  • Raised intracranial pressure or pre-existing neurological disorders, such as multiple sclerosis.
  • Patients with coagulopathy: platelets \< 100,000 INR ≥ 1.3 or therapeutic use of anti-coagulants.
  • Inability to communicate and understand the aim of the project.
  • Patients with history of allergic reaction to LA, DXM or Neostigmine.
  • Skin infection at injection site or systemic bacteremia.
  • Failure of the block and need for general anesthesia.

Arms & Interventions

DEXMEDETOMIDINE

Group 1 ( 18 patients ) were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (10 μg) DXM and 0.1 ml normal saline.

Intervention: DEXMEDETOMIDINE

Neostigmine

Group 2( 18 patients ) were received 10 mg (2ml) hyperbaric bupivacaine and 0.1 ml (50 μg) neostigmine and 0.1 ml normal saline.

Intervention: Neostigmine

Bupivacaine

Group 3 ( 18 patients ) were received 10 mg (2ml) hyperbaric bupivacaine and 0.2 ml normal saline as control.

Intervention: Bupivacaine

Outcomes

Primary Outcomes

Time started from the end of intrathecal injection till achievement of a bilateral sensory block at T10

Time Frame: 90 seconds

assessed by a pin prick needle from caudal to cephalic direction

Study Sites (1)

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