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

March 28, 2020 updated by: Georgia Micha, Saint Savvas Anticancer Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Anticancer Hospital of Athens "Saint Savvas"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group I
0.4 mgkg-1 of pethidine hydrochloride
Drug: 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
Experimental: Group II
2ml of ropivacaine (0.75%) with 15 mcg of fentanyl
Drug: Ropivacaine HCl Inj 7.5 MG/ML
In Group II patients will be administered with 2 ml of ropivacaine (0.75%)
Drug: Fentanyl
15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the pinprick test.
Time Frame: 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.
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.
Time Frame: 30 minutes after the intrathecal administration of the drug
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 Frame: 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.
30 minutes after the intrathecal administration of the drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride.
Time Frame: In the first 24 hours postoperatively
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.
In the first 24 hours postoperatively
Percentage of postsurgical catheter-related bladder discomfort
Time Frame: 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)
Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively
Assessment of haemodynamic status of patients intraoperatively
Time Frame: During the operation
In order to assess the haemodynamic status of patients intraoperatively we record all episodes of hypotension (drop of systolic pressure >30% of value before the subarachnoid block.
During the operation
Length of stay in postanesthesia care unit
Time Frame: 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.
Time of entry into postanesthesia care unit up to discharge to the ward or two hours time whichever comes first.
Adverse events
Time Frame: All adverse events observed intraoperatively and in the first 24 hours postoperatively
We record all adverse events observed intraoperatively and 24 hours postoperatively
All adverse events observed intraoperatively and in the first 24 hours postoperatively
Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride.
Time Frame: In the first 24 hours postoperatively
We also record the total amount of analgesics administered in morphine analogues in the first 24 hours postoperatively.
In the first 24 hours postoperatively
Assessment of haemodynamic status of patients intraoperatively
Time Frame: During the operation
We also record the total amount of intravenous fluids administered intraoperatively.
During the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saint Savvas Anticancer Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sofia Poulopoulou, Head of department, Anticancer Hospital of Athens 'Saint Savvas'

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • StSavvasAH 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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