Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.
- Conditions
- Low Dose of Pethidine for Subarachnoid Anesthesia
- Interventions
- Registration Number
- NCT03260283
- Lead Sponsor
- Saint Savvas Anticancer Hospital
- Brief Summary
The aim of this study is to assess the efficacy of subarachnoid anesthesia with low dose of pethidine (0.4mgkg-1) compared to administration of ropivacaine and fentanyl which is nowadays the common practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- All patients about to be subjected to Transurethral resection of the prostate (TURP) and Transurethral resection of urinary bladder tumors (TUR)
- Signed informed consent
- When subarachnoid block is contraindicated
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I Pethidine hydrochloride 0.4 mgkg-1 of pethidine hydrochloride Group II Ropivacaine HCl Inj 7.5 MG/ML 2ml of ropivacaine (0.75%) with 15 mcg of fentanyl Group II Fentanyl 2ml of ropivacaine (0.75%) with 15 mcg of fentanyl
- Primary Outcome Measures
Name Time Method Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the modified Bromage scale. 30 minutes after the intrathecal administration of the drug The level of motor block will be assessed by the modified Bromage scale.
Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the time of motor block establisment. 30 minutes after the intrathecal administration of the drug Time of motor block establishment (Grade 2 in modified Bromage scale) will be recorded as well as the time of withdrawal. Failure of spinal block is considered when there is no block at the level of first lumbar vertebra 30 minutes after the intrathecal administration of the drugs and in these cases the patients are excluded from the study.
Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the pinprick test. 30 minutes after the intrathecal administration of the drug Low dose of pethidine hydrochloride will be administered for subarachnoid anesthesia in patients subjected to urologic operations.The level of sensory block after subarachnoid anesthesia will be assessed by the pinprick test.
- Secondary Outcome Measures
Name Time Method Percentage of postsurgical catheter-related bladder discomfort Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively Assessment of discomfort will be made by a scale of four (1=no discomfort, 2=mild discomfort reported on questioning only, 3=moderate discomfort, urge to pass urine reported by the patient without questioning, 4= severe discomfort, urge to pass urine accompanied by behavioral responses, such as flailing limbs, strong vocal responses or attempts to pull the catheter out)
Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride. In the first 24 hours postoperatively We also record the total amount of analgesics administered in morphine analogues in the first 24 hours postoperatively.
Length of stay in postanesthesia care unit Time of entry into postanesthesia care unit up to discharge to the ward or two hours time whichever comes first. We record the total amount of time that patients stay in the postanesthesia care unit immediately after the operation until they are discharged to the ward. In order for a patient to be discharged to the ward he must have a score of more than \>9 in Aldrete's Scoring system.
Adverse events All adverse events observed intraoperatively and in the first 24 hours postoperatively We record all adverse events observed intraoperatively and 24 hours postoperatively
Assessment of haemodynamic status of patients intraoperatively During the operation We also record the total amount of intravenous fluids administered intraoperatively.
Trial Locations
- Locations (1)
Anticancer Hospital of Athens "Saint Savvas"
🇬🇷Athens, Greece
Anticancer Hospital of Athens "Saint Savvas"🇬🇷Athens, Greece