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

Saint Savvas Anticancer Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Low Dose of Pethidine for Subarachnoid Anesthesia

Treatments: Drug: Pethidine hydrochloride; Drug: Fentanyl; Drug: Ropivacaine HCl Inj 7.5 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT03260283

StSavvasAH 2

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 2 patient groups

Group I

Experimental group

Description:

0.4 mgkg-1 of pethidine hydrochloride

Treatment:

Drug: Pethidine hydrochloride

Group II

Experimental group

Description:

2ml of ropivacaine (0.75%) with 15 mcg of fentanyl

Treatment:

Drug: Fentanyl

Drug: Ropivacaine HCl Inj 7.5 MG/ML