Clinical trial NCT03260283: Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.
Official title: Assessment of Subarachnoid Anesthesia With Low Dose of Pethidine and Combination of Ropivacaine With Fentanyl for Urologic Surgical Operations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Low Dose of Pethidine for Subarachnoid Anesthesia
Keywords: pethidine
Lead sponsor: Saint Savvas Anticancer Hospital
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 104
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized control trial
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the pinprick test.
timeFrame: 30 minutes after the intrathecal administration of the drug
measure: Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the modified Bromage scale.
timeFrame: 30 minutes after the intrathecal administration of the drug
measure: 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.
timeFrame: 30 minutes after the intrathecal administration of the drug
Secondary outcomes:
measure: Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride.
timeFrame: In the first 24 hours postoperatively
measure: Percentage of postsurgical catheter-related bladder discomfort
timeFrame: Change from preoperative status to postoperative one at 0, 1, 2, 6, 24 hours postoperatively
measure: Assessment of haemodynamic status of patients intraoperatively
timeFrame: During the operation
measure: Length of stay in postanesthesia care unit
timeFrame: Time of entry into postanesthesia care unit up to discharge to the ward or two hours time whichever comes first.
measure: Adverse events
timeFrame: All adverse events observed intraoperatively and in the first 24 hours postoperatively
measure: Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride.
timeFrame: In the first 24 hours postoperatively
measure: Assessment of haemodynamic status of patients intraoperatively
timeFrame: During the operation
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Anticancer Hospital of Athens "Saint Savvas"
Study officials:
affiliation: Anticancer Hospital of Athens 'Saint Savvas'
name: Sofia Poulopoulou, Head of department
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.