English Title: Comparison of the effect of adding magnesium sulfate and midazolam to 0.5% bupivacaine spinally in reducing postoperative pain in patients who are candidates for ureteric stone surgery
Comparison of the effect of adding magnesium sulfate and midazolam to 0.5% bupivacaine spinally in reducing postoperative pain in patients who are candidates for ureteric stone surgery
Design
In this double-blind, randomized clinical trial,60 patients undergoing TUL surgery under spinal anesthesia at Amir al-Momnin Hospital, Arak, will be enrolled. Following informed written consent and verification of inclusion and exclusion criteria,
Settings and conduct
The study will be conducted in the operating room of Amir Al-Momenin Hospital in Arak. After informed consent, patients will be allocated to groups using block randomization. Patients, outcome assessors, and data analysts will be blinded to the intervention, and blinding will be maintained by an independent anesthesiologist. The patients will then be randomly allocated into two groups using a block randomization method. Spinal anesthesia will be performed at the L3–L4 or L4–L5 intervertebral space using a 25–26 gauge Quincke needle by a single operator, and patients in each group will receive the specified spinal medications. supine position, and the surgical operation will be carried out.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• Age between 18 and 60 years
• American Society of Anesthesiologists physical status class I or
• Candidates for transureteral lithotripsy (TUL) surgery
• Body mass index less than 30
Exclusion Criteria
• Patient refusal to undergo spinal anesthesia
Intervention groups
Midazolam Group (M): Patients will receive 2 mg of preservative-free midazolam in combination with 15 mg of 0.5% hyperbaric bupivacaine. Magnesium Sulfate Group (S): Patients will receive 100 mg of magnesium sulfate in combination with 15 mg of 0.5% hyperbaric bupivacaine.
Main outcome variables
average blood pressure and pulse rate ،pain ، time of arrival sensor and motor block،complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260124068652N1
Registration date:2026-06-17, 1405/03/27
Registration timing:registered_while_recruiting
Last update:2026-06-17, 1405/03/27
Update count:0
Registration date
2026-06-17, 1405/03/27
Registrant information
Name
Shadi Rostamikia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 905 693 4020
Email address
emadbulters1976@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-02, 1405/03/12
Expected recruitment end date
2026-07-09, 1405/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
English Title: Comparison of the effect of adding magnesium sulfate and midazolam to 0.5% bupivacaine spinally in reducing postoperative pain in patients who are candidates for ureteric stone surgery
Public title
Effect of sulfate magnesium and midazolam in reducimg pain in pation who candidates for tul
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 60 years old
Asa class 1 and 2
Patients who candidates for tul
Exclusion criteria:
Existential body mass index more than 30
ssensitivness to useful drugs
cardiovascular problems
coagolopathy
arrhythmia
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated into two groups using block randomization with block sizes of 2 and 4. The random sequence will be generated by an independent individual who is not involved in participant recruitment or assessment, using the online program available on the Sealed Envelope website. After confirming eligibility criteria and obtaining informed consent, each participant will receive a unique identification number in the order of enrollment and will be assigned to one of the two groups according to the pre‑generated random sequence. Allocation concealment will be ensured using opaque, sealed, and sequentially numbered envelopes containing each participant’s group assignment.
Blinding (investigator's opinion)
Double blinded
Blinding description
"To ensure a double-blind design, data will be measured and recorded by an intern who is unaware of the group allocations. Medication preparation for each group will be performed by a nurse anesthetist, while the spinal anesthesia will be administered by an anesthesiologist. Consequently, due to the lack of knowledge regarding group sequences and interventions among both the patients and the outcome assessors, the study will be double-blinded."
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of arak medical university
Street address
Sardasht basij square
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2025-12-21, 1404/09/30
Ethics committee reference number
IR.ARAKMU.REC.1404.393
Health conditions studied
1
Description of health condition studied
postoperative pain in patients who are candidates for ureteric stone surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative pain
Timepoint
1,2,4,612 hours after operation
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Midazolam Group (M): Patients will receive 2 mg of preservative-free midazolam ( caspian pharmaceutical co , Rasht iran ) in combination with 15 mg of 0.5% hyperbaric bupivacaine. the drug is administered as a single bolus injection during spinal anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group: Magnesium Sulfate Group (S): Patients will receive 100 mg of magnesium sulfate ( 10% solution , pasteur institue of iran ) in combination with 15 mg of 0.5% hyperbaric bupivacaine. the drug is administered as a single bolus injection during spinal anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr alireza kamali
Street address
Sardasht, amir almomenin hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 905 693 4020
Email
it_amiralmomenin@arakmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr behzad khansari nezhad
Street address
Sardasht, basij square, studious assistance
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 905 693 4020
Email
behzad.khansarinejad@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Shadi rostamikia
Position
attend
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shahid shirudi street , valiasr square , valiasr hospital