Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.

Saint Savvas Anticancer Hospital104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

104

Conditions

Low Dose of Pethidine for Subarachnoid Anesthesia

Interventions

Pethidine hydrochlorideDRUG

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/MLDRUG

In Group II patients will be administered with 2 ml of ropivacaine (0.75%)

FentanylDRUG

15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients about to be subjected to Transurethral resection of the prostate (TURP) and Transurethral resection of urinary bladder tumors (TUR) * Signed informed consent Exclusion Criteria: * 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

Locations (1)

Anticancer Hospital of Athens "Saint Savvas"

Athens, Greece

Outcomes

Primary Outcomes

Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the pinprick test.

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.

Time frame: 30 minutes after the intrathecal administration of the drug

Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the modified Bromage scale.

The level of motor block will be assessed by the modified Bromage scale.

Time frame: 30 minutes after the intrathecal administration of the drug

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.

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.

Time frame: 30 minutes after the intrathecal administration of the drug

Secondary Outcomes

Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride.

In order to assess the efficacy of analgesia provided by the low dose of pethidine hydrochloride we record the time at which patients ask analgesic for the first time after the operation.

Time frame: In the first 24 hours postoperatively

Percentage of postsurgical catheter-related bladder discomfort

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)

Data from ClinicalTrials.gov

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