Effect of Intravenous or Intrathecal Dexmedetomidine on Bupivacaine Spinal Block in Lower Abdominal Surgery

NCT06654531 | Completed Phase 2 FDA Drug

• 1 other identifier: 66
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a comparative study will be carried out after approval by the Local Ethical Committee in Al-Azhar University hospital (Assiut) and after obtaining patients' written informed consent. 50 ASA physical status I-II aged 20-60 years of both sexes scheduled for lower abdominal surgery with an expected duration of 90-120 min under spinal anesthesia will be enrolled in this study Primary outcome : \- The onset and duration of sensory and motor blockade ,Postoperative analgesic efficacy . Secondary outcomes : \- to assess the effect on hemodynamics and postoperative analgesic requirement All patients will be assigned randomly into two groups :group 1 (the I.V group ) Patients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery. intrathecal group (n = 25) patients received intrathecal 15 mg hyperbaric bupivacaine (Marcaine 0.5%; Astra Zeneca, UK) together with 5 μg Dexmedetomidine (Precedex; Abbott; Chicago, IL, USA, 100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery.

Conditions

Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Outcome Measures

Primary Outcomes (2)

• Postoperative analgesic efficacy

  duration of sensory blockade of spinal anaesthesia

  15 minutes intervals for 12 hours postoperatively

• Postoperative analgesic efficacy

  duration of motor blockade of spinal anesthesia

  20 minutes intervals for 12 hours postoperatively

Secondary Outcomes (4)

• Haemodynamics

  1 hours intervals from start of operation until 12 hours postoperatively

• Assessment of pain

  every 1 hour intervals until 12 hours postoperatively

• Assessment of sedation

  every 30 minutes intervals for 12 hours postoperatively

• hemodynamics

  1 hours intervals from start of operation until 12 hours postoperatively

Study Arms (2)

group 1 (I.V group )

ACTIVE COMPARATOR

Patients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery.

Drug: Dexmedetomidine

group 2 (intrathecal group)

ACTIVE COMPARATOR

25 patients received intrathecal 15 mg hyperbaric bupivacaine (Marcaine 0.5%; Astra Zeneca, UK) together with 5 μg Dexmedetomidine (Precedex; Abbott; Chicago, IL, USA, 100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Under a sterile technique, spinal anesthesia will be carried out using a 22-G Quincke spinal needle after skin infiltration with 2% lidocaine 3 ml a t the L3-L4 level, a midline approach in the sitting position, and then in the supine position. Th e time of spinal injection will be considered time zero (T0). The I.V drug regimen will be started according to the group to which patients will be assigned.patients will receive intrathecal 15 mg hyperbaric bupivacaine together with 5 μg Dexmedetomidine in group 2

group 1 (I.V group ); group 2 (intrathecal group)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA physical status I-II
• lower abdominal surgery
• Aged 20-60 years of both sexes

You may not qualify if:

• Patient refusal.
• history of cardiac, hepatic, neurological, or renal disease.
• BMI ≥30kg/ m2 (Morbid obesity).
• Patients with diabetes mellitus.
• history of allergy to study drugs, any contraindication for regional anesthesia
• Coagulopathy.
• failed or unsatisfactory spinal block.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Azhar University

Asyut, Assuit, 71111, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• ezzat m ali el soudy, professor

  professor of anaesthesia and icu

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: All patients will be assigned randomly into two groups :group 1 (the I.V group ) Patients in the I.V group (n = 25) received intrathecal hyperbaric bupivacaine 15 mg together with NSS 0.5 ml, followed by an I.V bolus dose of dexmedetomidine 0.5 μg/kg over 10 min and then an I.V infusion of a maintenance dose of 0.5 μg/kg/h (200 μg dexmedetomidine in 2 ml added to 48 ml NSS yielded dexmedetomidine 4 μg /ml) for the entire period of surgery. intrathecal group (n = 25) patients received intrathecal 15 mg hyperbaric bupivacaine together with 5 μg Dexmedetomidine 100 μg/ml diluted with normal saline solution (NSS) to 10 μg/ml), followed by an NSS I.V bolus and an I.V infusion of maintenance volume equivalent to that of the I.V group throughout the entire period of the surgery.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: October 23, 2024
• Study Start: January 2, 2022
• Primary Completion: December 30, 2023
• Study Completion: March 10, 2024
• Last Updated: October 23, 2024

Record last verified: 2023-06

Locations

EG (1)