Low Dose of Pethidine for Subarachnoid Anesthesia
Conditions
Keywords
pethidine
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.
Interventions
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
In Group II patients will be administered with 2 ml of ropivacaine (0.75%)
DRUGFentanyl
15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations
Sponsors
Saint Savvas Anticancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Double blind randomized control trial
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the pinprick test. | 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. |
| Efficacy of subarachnoid anesthesia after administration of low dose of pethidine hydrochloride as the sole anesthetic agent, assessed by the modified Bromage scale. | 30 minutes after the intrathecal administration of the drug | The level of motor block will be assessed by the modified Bromage scale. |
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Efficacy and length of time of analgesia provided by the low dose of pethidine hydrochloride. | 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. |
| Adverse events | All adverse events observed intraoperatively and in the first 24 hours postoperatively | We record all adverse events observed intraoperatively and 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 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) |
| Assessment of haemodynamic status of patients intraoperatively | 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. |
Countries
Greece
Outcome results
None listed