Intrathecal Fentanyl and Dexmedetomidine Added to Bupivacaine for Subarachnoid Anaesthesia for Percutaneous Nephrolithotomy

NCT ID: NCT06957301

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2025-12-31

Brief Summary

Regular bupivacaine dosages are linked to considerable sympathetic block, as well as persistent and severe sensory and motor block, which may not be desired for certain individuals. Although diluted bupivacaine at low doses restricts the distribution of spinal block and produces a comparatively quick recovery, it might not offer a sufficient degree of sensory block.Bupivacaine's side effects and dosage requirements are lessened by the potentiating effects of the short-acting lipophilic opioid fentanyl and the more selective α2 agonist dexmedetomidine. These spinal adjuncts are used to extend analgesia in addition to lessening the negative effects of local anesthetics. According to a number of studies, when given intrathecally, α2 receptor agonists will increase the analgesia that subtherapeutic doses of local anesthetics like bupivacaine deliver because of their synergistic effects with little hemodynamic effects.The goal will be to determine if bupivacaine and fentanyl or bupivacaine and dexmedetomidine produced higher-quality anesthesia.

Detailed Description

Spinal anesthesia is a straightforward procedure that acts quickly. However, because of its neurotoxic effects, a common anesthetic like lidocaine has mostly been substituted by alternative substances like bupivacaine. Regular bupivacaine dosages are linked to considerable sympathetic block, as well as persistent and severe sensory and motor block, which may not be desired for certain individuals. Although diluted bupivacaine at low doses restricts the distribution of spinal block and produces a comparatively quick recovery, it might not offer a sufficient degree of sensory block. Bupivacaine's side effects and dosage requirements are lessened by the potentiating effects of the short-acting lipophilic opioid fentanyl and the more selective α2 agonist dexmedetomidine. These spinal adjuncts are used to extend analgesia in addition to lessening the negative effects of local anesthetics.

The danger of respiratory depression for lipophilic opioids, such as fentanyl and sufentanil, is primarily restricted to the first two hours following intrathecal injection. Because fentanyl is more lipid soluble than morphine, there is a significantly lower chance of delayed respiratory depression brought on by the rostral distribution of an intrathecal injected drug to respiratory centers.

Both visceral and somatic pain can be reduced by intrathecal α2 receptor agonists. Compared to clonidine (α2/α1 200:1), dexmedetomidine has greater selectivity for the α2 receptor (α2/α1 1600:1). According to a number of studies, when given intrathecally, α2 receptor agonists will increase the analgesia that subtherapeutic doses of local anesthetics like bupivacaine deliver because of their synergistic effects with little hemodynamic effects. The goal will be to determine if bupivacaine and fentanyl or bupivacaine and dexmedetomidine produced higher-quality anesthesia.

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Objective:

The study's main goal is to evaluate patient satisfaction and sedation level. Comparing the two groups' analgesia duration, initial post-operative analgesia request, analgesia onset time (measured by pinpricking the T6 block level), peak block time, degree of motor blockade, and hemodynamic profiles will be the secondary outcome.

Methods and patients:

After obtaining Institutional Ethical Committee approval, this prospective randomised double-blinded study was carried out in a tertiary health care centre on 100 patients After obtaining Institutional Ethical Committee approval, this prospective randomised double-blinded study will be carried out in a tertiary health care centre on 100 patients of

Intervention:

Spinal anaesthesia will be performed in all patients in the sitting position. Under strict aseptic precautions, using 25G Quincke needle mid-line spinal puncture was performed at L2-L3 level.

In Group fentanyl (F), an injection of bupivacaine 0.5% (3.5 ml) + fentanyl 0.5 ml (25 μg) was administered intrathecally.

In Group dexmedetomidine( D), dexmedetomidine will be first diluted in normal saline to obtain a dose of 5 μg in 0.5 ml. Then, an injection of bupivacaine 0.5% (3.5 ml) + dexmedetomidine 0.5 ml (5 μg) will be administered intrathecally. Drug will be administered over 10 seconds (s) using 5 cc syringes with cephalad orientation of the spinal needle bevel. The patients were turned supine immediately after the injection of the drug.

Midazolame and fentanyle will be administered on request as rescue analgesic and for sedation if needed . post-operatively and side-effects such as hypotension, bradycardia, pruritus, vomiting, respiratory depression were also monitored. Pruritus was managed with i.v chlorpheniramine maleate.

Conditions

Percutaneous Nephrolithotomy (PCNL)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group fentanyl (F)

an injection of bupivacaine 0.5% (3.5 ml) + fentanyl 0.5 ml (25 μg) will be given intrathecal

Group Type: ACTIVE_COMPARATOR

Intrathecal Fentanyl Group (F)

Intervention Type: PROCEDURE

Group fentanyl (F), an injection of bupivacaine 0.5% (3.5 ml) + fentanyl 0.5 ml (25 μg) will be administered intrathecally.

Group dexmedetomidine( D)

In Group dexmedetomidine( D), dexmedetomidine will be first diluted in normal saline to obtain a dose of 5 μg in 0.5 ml. Then, an injection of bupivacaine 0.5% (3.5 ml) + dexmedetomidine 0.5 ml (5 μg) will be administered intrathecally. Drug will be administered over 10 seconds (s) using 5 cc syringes with cephalad orientation of the spinal needle bevel.

Group Type: ACTIVE_COMPARATOR

intrathecal dexmedetomidine group(D)

Intervention Type: PROCEDURE

Group dexmedetomidine( D), dexmedetomidine will be first diluted in normal saline to obtain a dose of 5 μg in 0.5 ml. Then, an injection of bupivacaine 0.5% (3.5 ml) + dexmedetomidine 0.5 ml (5 μg) will be administered intrathecally. Drug will be administered over 10 seconds (s) using 5 cc syringes with cephalad orientation of the spinal needle bevel.

Interventions

Intrathecal Fentanyl Group (F)

Group fentanyl (F), an injection of bupivacaine 0.5% (3.5 ml) + fentanyl 0.5 ml (25 μg) will be administered intrathecally.

Intervention Type: PROCEDURE

intrathecal dexmedetomidine group(D)

Group dexmedetomidine( D), dexmedetomidine will be first diluted in normal saline to obtain a dose of 5 μg in 0.5 ml. Then, an injection of bupivacaine 0.5% (3.5 ml) + dexmedetomidine 0.5 ml (5 μg) will be administered intrathecally. Drug will be administered over 10 seconds (s) using 5 cc syringes with cephalad orientation of the spinal needle bevel.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• both sex aged between 18 and 60 years,
• belonging to American Society of Anaesthesiologists (ASA) physical status Grade I and II undergoing PCNL under spinal anaesthesia.

Exclusion Criteria

• Patients with a history of spine surgery,
• infection at the injection site,
• coagulopathy,
• hypovolemia,
• increased intracranial pressure,
• indeterminate neurologic disease,
• spinal deformities,
• communication problems,
• known hypersensitivity to local anaesthetics, opioids or dexmedetomidine

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Islam Elbardan, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Locations

Faculty of medicine ,Alexandria university

Alexandria, Alexandria Governorate, Egypt

Countries

Egypt

Other Identifiers

serial number:0307226

Identifier Type: -

Identifier Source: org_study_id