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Completed

NCT Number: NCT03260283

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

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.

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Key information

Conditions

Low Dose of Pethidine for Subarachnoid Anesthesia

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Anticancer Hospital of Athens "Saint Savvas"

Athens, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Ropivacaine HCl Inj 7.5 MG/ML

Drug

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

Fentanyl

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. Assessment of haemodynamic status of patients intraoperatively

    Time frame: During the operation

    We also record the total amount of intravenous fluids administered intraoperatively.

Sponsors and collaborators

Lead sponsor

Saint Savvas Anticancer Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 24, 2017
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.