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

NCT06957301 | Active Not Recruiting

• 1 other identifier: serial number:0307226
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Percutaneous Nephrolithotomy (PCNL)

Keywords

percutaneous nephrolithotomy; intrathecal additive; dexametamodine; fentanyl

Outcome Measures

Primary Outcomes (2)

• to evaluate patient satisfaction

  The level of patient's satisfaction was measured using five-point Likert scale ((1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied)

  at the end of the surgery (assessed up to 40 minutes)

• to evaluate the sedation grade

  5- Ramsay Sedation Score 1. \- Anxious, agitated/restless or both 2. \- Patient cooperative, oriented, and tranquil 3. \- Patient responds to commands only 4. \- Brisk response to a light glabellar tap or loud auditory stimulus 5. \- Sluggish response to light glabellar tap or loud auditory stimulus 6. \- Patient shows no response.

  10 minutes after giving the intervention , then after 30 minutes , then at the end of the surgery (assessed up to 40 minutes)

Secondary Outcomes (6)

• to compare analgesia onset, duration ,peak sensory level

  after giving the intervention every 1 minutes till reach level T6 (assessed up to 10 minutes)

• to compare the initial post-operative analgesia request

  24 hour after surgery

• to compare the degree of motor blockade between the two groups

  at the time of peak sensory (up to 10 minutes) and then every 1hour for 3 hours post operative

• to compare the mean arterial blood pressure between the two groups

  every 5 min up to 15 min after the intervention , then every 15 min during surgery and then for each hour after surgery in the ward(up to 4 hour).

• to record Post-operative and intraoperative complications

  during the procedure ,24 hour postoperatively

Study Arms (2)

Group fentanyl (F)

ACTIVE COMPARATOR

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

Procedure: Intrathecal Fentanyl Group (F)

Group dexmedetomidine( D)

ACTIVE COMPARATOR

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.

Procedure: intrathecal dexmedetomidine group(D)

Interventions

Intrathecal Fentanyl Group (F) PROCEDURE

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

Group fentanyl (F)

intrathecal dexmedetomidine group(D) 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.

Group dexmedetomidine( D)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of medicine ,Alexandria university

Alexandria, Alexandria Governorate, 21521, Egypt

Location

Study Officials

• Islam Elbardan, Dr

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized superiority trial.

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: May 4, 2025
• Study Start: April 10, 2025
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)