Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.
NCT ID: NCT03260283
Last Updated: 2020-03-31
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
104 participants
INTERVENTIONAL
2017-08-16
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Group I
0.4 mgkg-1 of pethidine hydrochloride
Pethidine hydrochloride
In Group I patients will be administered with low dose of pethidine hydrochloride (0.4 mgkg-1) diluted into normal saline up to 2 ml of total volume in order to perform subarachnoid anesthesia for urologic operations
Group II
2ml of ropivacaine (0.75%) with 15 mcg of fentanyl
Ropivacaine HCl Inj 7.5 MG/ML
In Group II patients will be administered with 2 ml of ropivacaine (0.75%)
Fentanyl
15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations
Interventions
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Pethidine hydrochloride
In Group I patients will be administered with low dose of pethidine hydrochloride (0.4 mgkg-1) diluted into normal saline up to 2 ml of total volume in order to perform subarachnoid anesthesia for urologic operations
Ropivacaine HCl Inj 7.5 MG/ML
In Group II patients will be administered with 2 ml of ropivacaine (0.75%)
Fentanyl
15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
* Patient's denial in performing subarachnoid anesthesia
* Failure of subarachnoid block (L1 dermatome in 30 minutes after intrathecal drug administration)
* Mental illness or drug abuse
* Estimated time of operation \>90 minutes
55 Years
ALL
No
Sponsors
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Saint Savvas Anticancer Hospital
OTHER
Responsible Party
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Georgia Micha
Anesthesiologist,MD, MSc, PhD
Principal Investigators
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Sofia Poulopoulou, Head of department
Role: STUDY_DIRECTOR
Anticancer Hospital of Athens 'Saint Savvas'
Locations
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Anticancer Hospital of Athens "Saint Savvas"
Athens, , Greece
Countries
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References
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Luck JF, Fettes PD, Wildsmith JA. Spinal anaesthesia for elective surgery: a comparison of hyperbaric solutions of racemic bupivacaine, levobupivacaine, and ropivacaine. Br J Anaesth. 2008 Nov;101(5):705-10. doi: 10.1093/bja/aen250. Epub 2008 Sep 2.
Mohta M. Ropivacaine: Is it a good choice for spinal anesthesia? J Anaesthesiol Clin Pharmacol. 2015 Oct-Dec;31(4):457-8. doi: 10.4103/0970-9185.169050. No abstract available.
Lewis RP, Spiers SP, McLaren IM, Hunt PC, Smith HS. Pethidine as a spinal anaesthetic agent--a comparison with plain bupivacaine in patients undergoing transurethral resection of the prostate. Eur J Anaesthesiol. 1992 Mar;9(2):105-9.
Other Identifiers
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StSavvasAH 2
Identifier Type: -
Identifier Source: org_study_id
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