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

NCT03260283 | Completed Phase 2

• 1 other identifier: StSavvasAH 2
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Dose of Pethidine for Subarachnoid Anesthesia

Keywords

pethidine

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  30 minutes after the intrathecal administration of the drug

Secondary Outcomes (7)

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

  In the first 24 hours postoperatively

• Percentage of postsurgical catheter-related bladder discomfort

  Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively

• Assessment of haemodynamic status of patients intraoperatively

  During the operation

• 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.

• Adverse events

  All adverse events observed intraoperatively and in the first 24 hours postoperatively

Study Arms (2)

Group I

EXPERIMENTAL

0.4 mgkg-1 of pethidine hydrochloride

Drug: Pethidine hydrochloride

Group II

EXPERIMENTAL

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

Drug: Ropivacaine HCl Inj 7.5 MG/ML; Drug: Fentanyl

Interventions

Pethidine hydrochloride DRUG

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 I

Ropivacaine HCl Inj 7.5 MG/ML DRUG

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

Group II

Fentanyl DRUG

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

Group II

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients about to be subjected to Transurethral resection of the prostate (TURP) and Transurethral resection of urinary bladder tumors (TUR)
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Savvas Anticancer Hospital: lead

Study Sites (1)

Anticancer Hospital of Athens "Saint Savvas"

Athens, Greece

Location

Related Publications (3)

• 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.

  PMID: 18765643 BACKGROUND

• 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.

  PMID: 26702199 BACKGROUND

• 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.

  PMID: 1555549 BACKGROUND

MeSH Terms

Interventions

Meperidine; Fentanyl

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sofia Poulopoulou, Head of department

  Anticancer Hospital of Athens 'Saint Savvas'

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist,MD, MSc, PhD

Model Details: Double blind randomized control trial

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 24, 2017
• Study Start: August 16, 2017
• Primary Completion: November 29, 2018
• Study Completion: December 31, 2019
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

GR (1)