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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05610007
Other study ID # IndonesiaUAnes125
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2022
Est. completion date November 1, 2022

Study information

Verified date November 2022
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Data regarding the comparison of recovery time from spinal anesthesia between prilocaine and bupivacaine are still relatively limited. The aim of this study was to compare the speed of recovery of spinal anesthesia with hyperbaric prilocaine 2% 50 mg compared to hyperbaric bupivacaine 0.5% 12.5 mg in cystoscopy procedures. By knowing the speed of recovery time, it is hoped that the patient will recover faster, be transferred to the treatment room faster, be safer, and the length of treatment will be shorter so that the quality of service for cystoscopy procedures and patient satisfaction is getting better.


Description:

This study is a double-blind randomized clinical trial. This study compared the speed of recovery from spinal anesthesia, as many as 66 subjects were divided into two groups, namely hyperbaric prilocaine 2% 50 mg and hyperbaric bupivacaine 0.5% 12.5 mg who would undergo a cystoscopy procedure. This research was conducted in the urological surgery room of RSCM in January - October 2022, after passing the ethical review and obtaining a location permit.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 66
Est. completion date November 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Male or female over the age of 18, - ASA physical status I - III, - Normal body mass index according to Quetelet's index, - Willing to be a research participant and comply with the research rules. Exclusion Criteria: - Have a history of allergy to prilocaine or bupivacaine, - Have a previous history of walking disorders - Spinal anesthesia is contraindicated.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Prilocaine
Patients in the prilocaine group were given 50 mg hyperbaric 2% prilocaine (2.5 ml volume) + 25 mcg fentanyl (0.5 ml volume) before undergoing the cystoscopy procedure.

Locations

Country Name City State
Indonesia Cipto Mangunkusumo Cental National Hospital Jakarta DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analog scale (VAS) Pain measurement scale felt by patients with a score of 0 = no pain and a score of 10 = unbearable severe pain. 24 hour
Secondary Complication Complications that occur due to spinal drug administration, such as chills, hypotension, postoperative nausea and vomiting. 24 hour
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