Percutaneous Nephrolithotomy (PCNL)NCT06957301
Intrathecal Fentanyl and Dexmedetomidine Added to Bupivacaine for Subarachnoid Anaesthesia for Percutaneous Nephrolithotomy
A study testing Intrathecal Fentanyl Group (F) and intrathecal dexmedetomidine group(D) in people with Percutaneous Nephrolithotomy (PCNL), run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Percutaneous Nephrolithotomy (PCNL)
- What is being tested?
- Intrathecal Fentanyl Group (F) and intrathecal dexmedetomidine group(D)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2025to 4 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with a history of spine surgery,
- infection at the injection site,
- coagulopathy,
- hypovolemia,
- increased intracranial pressure,
- indeterminate neurologic disease,
Show all 9Show fewer
- spinal deformities,
- communication problems,
- known hypersensitivity to local anaesthetics, opioids or dexmedetomidine
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine ,Alexandria university
Alexandria, Alexandria Governorate, 21521
About this study
Official title: Intrathecal Fentanyl and Dexmedetomidine Added to Bupivacaine for Subarachnoid Anaesthesia for Percutaneous Nephrolithotomy: A Randomized Superiority Trial
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.
Read the 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.
.
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 60 patients After obtaining Institutional Ethical Committee approval, this prospective randomised double-blinded study will be carried out in a tertiary health care centre on 60 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, shivering, respiratory depression were also monitored. Pruritus was managed with i.v chlorpheniramine maleate.
- Conditions
- Percutaneous Nephrolithotomy (PCNL)
- Being tested
- Intrathecal Fentanyl Group (F), intrathecal dexmedetomidine group(D)
- Keywords
- percutaneous nephrolithotomy, intrathecal additive, dexametamodine, fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal Fentanyl Group (F)Procedure or surgery
Group fentanyl (F), an injection of bupivacaine 0.5% (3.5 ml) + fentanyl 0.5 ml (25 μg) will be administered intrathecally.
intrathecal dexmedetomidine group(D)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group fentanyl (F) | Active comparator | an injection of bupivacaine 0.5% (3.5 ml) + fentanyl 0.5 ml (25 μg) will be given intrathecal Receives: 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. Receives: Procedure: intrathecal dexmedetomidine group(D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at the end of the surgery (assessed up to 40 minutes)
to evaluate the sedation grade
5- Ramsay Sedation Score
- - Anxious, agitated/restless or both
- - Patient cooperative, oriented, and tranquil
- - Patient responds to commands only
- - Brisk response to a light glabellar tap or loud auditory stimulus
- - Sluggish response to light glabellar tap or loud auditory stimulus
- - Patient shows no response.
Measured: 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
Sensory block level which will be defined as the loss of pain sensation to pin prick test in the midclavicular line, will be measured every1 min until it reached T6 level, and the surgeons will be asked to start. And record the time to reach peak sensory level .
Measured: after giving the intervention every 1 minutes till reach level T6 (assessed up to 10 minutes)
to compare the initial post-operative analgesia request
recording the time the patient need rescue analgesia post operative
Measured: 24 hour after surgery
to compare the onset,duration of motor blockade between the two groups
Motor block of lower limbs was assessed bilaterally using a modified Bromage scale as 0=no paralysis, 1=cannot raise extended leg, 2=cannot flex the knee, and 3=cannot dorsiflex the ankle.
Measured: Motor power assessment was done every five minutes, for 30 min after spinal anesthesia, and then every 20 min until the end of surgery. The time to achieve Bromage 3 was considered an onset of the motor block. Duration of motor block was considered until
to compare the mean arterial blood pressure between the two groups
Mean blood pressure will be recorded every 5 min up to 15 min and then every 15 min during surgery then for each hour after surgery in the ward (up to 4 hour) .
Hypotension, defined as mean BP less than 60 mm Hg will be treated by injection of ephedrine and crystalloids intravenous .
Measured: 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
Post-operative and intraoperative complications (respiratory depression, hypotension, bradaycardia,shivering ,vomiting ,nausea,pruitis)
Measured: during the procedure ,24 hour postoperatively
to compare heart rate between to groups
Heart rate (HR) will be recorded every 5 min up to 15 min and then every 15 min during surgery then for each hour after surgery in the ward.
Bradycardia was defined as HR <60 beats/min will be treated with intravenous atropine 0.3 mg increments.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start10 Apr 2025
- Primary completion4 Mar 2026
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Nephrolithotomy (PCNL)Studies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized superiority trial.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Islam Elbardan, Dr, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957301
- Sponsor's protocol ID
- serial number:0307226
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Fentanyl and Dexmedetomidine Added to Bupivacaine for Subarachnoid Anaesthesia for Percutaneous Nephrolithotomy: A Randomized Superiority Trial
- ClinicalTrials.gov ID
- NCT06957301
- Acronym / sponsor ID
- serial number:0307226
- Conditions
- Percutaneous Nephrolithotomy (PCNL)
- Keywords
- percutaneous nephrolithotomy, intrathecal additive, dexametamodine, fentanyl
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 4 Mar 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
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 60 patients After obtaining Institutional Ethical Committee approval, this prospective randomised double-blinded study will be carried out in a tertiary health care centre on 60 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, shivering, respiratory depression were also monitored. Pruritus was managed with i.v chlorpheniramine maleate.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Group fentanyl (F) | Active comparator | Procedure: Intrathecal Fentanyl Group (F)an injection of bupivacaine 0.5% (3.5 ml) + fentanyl 0.5 ml (25 μg) will be given intrathecal |
| Group dexmedetomidine( D) | Active comparator | Procedure: intrathecal dexmedetomidine group(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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- Patients with a history of spine surgery,
- infection at the injection site,
- coagulopathy,
- hypovolemia,
- increased intracranial pressure,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group fentanyl (F) |
| 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. | Procedure or surgery | Group dexmedetomidine( D) |
Primary outcome
to evaluate patient satisfaction
Time frame: at the end of the surgery (assessed up to 40 minutes)
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)
to evaluate the sedation grade
Time frame: 10 minutes after giving the intervention , then after 30 minutes , then at the end of the surgery (assessed up to 40 minutes)
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.
6 secondary outcomes
to compare analgesia onset, duration ,peak sensory level
Time frame: after giving the intervention every 1 minutes till reach level T6 (assessed up to 10 minutes)
to compare the initial post-operative analgesia request
Time frame: 24 hour after surgery
to compare the onset,duration of motor blockade between the two groups
Time frame: Motor power assessment was done every five minutes, for 30 min after spinal anesthesia, and then every 20 min until the end of surgery. The time to achieve Bromage 3 was considered an onset of the motor block. Duration of motor block was considered until
to compare the mean arterial blood pressure between the two groups
Time frame: 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
Time frame: during the procedure ,24 hour postoperatively
to compare heart rate between to groups
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Islam Elbardan, Dr principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Fentanyl Group (F) and intrathecal dexmedetomidine group(D) in people with Percutaneous Nephrolithotomy (PCNL), run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate patient satisfaction (time frame: at the end of the surgery (assessed up to 40 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.