Comparing two drugs in reducing catheter related bladder discomfort among patients undergoing bladder surgeries
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2025/06/088234
- Lead Sponsor
- PGIMER, Chandigarh, India
- Brief Summary
After approval from the Institute Ethics Committee, PGIMER, Chandigarh, written informed consent will be obtained from all patients before enrollment in this randomised controlled study.
All patients will undergo standard pre-anaesthetic exam. The patients who meet the inclusion criteria will be included in the study.
The procedure will be explained and consent will be taken.
92 patients will be randomly divided into group L (Lidocaine) or group S (Solifenacin) in a 1:1 ratio using a computer-generated list concealed by sealed opaque envelopes.
Fasting of the patients will be confirmed
After randomization the patients who are assigned to Group S will receive oral Solifenacin 5 mg 2 hours prior to the surgery and Group L will receive oral placebo.
Once the patient enters the operating room, ASA standard monitors will be attached, a warming device will also be attached. IV access will be taken and the patient will receive intravenous fluid
Baseline vitals (HR, SpO2, SBP, DBP, MAP) will be recorded.
General anesthesia will be given following standard protocol with IV Fentanyl (2mcgs/kg), and IV Propofol(1-2.5mg/kg) with or without muscle relaxation (requirement based on tumor location).
The airway will be secured by an appropriate size Supraglottic airway device or Endotracheal tube at the discretion of the treating anesthesiologist.
Patient in Group L will receive transurethral bladder irrigation of normal saline with 0.02% lidocaine at the end of surgery with a contact time of 10 minutes, and their Foley’s balloon will be inflated with 2% lignocaine 10ml
Patients in Group S will receive normal saline bladder irrigation at the end of surgery and their Foley’s balloon will be inflated with 10 ml normal saline
At the end of surgery, the neuromuscular blocking agent will be antagonized with a combination of neostigmine 0.05 mg/ kg and glycopyrrolate 0.01 mg/kg
Patients will be extubated and transferred to PACU once they are fully conscious and maintaining adequate spontaneous ventilation.
Post surgery an assessment of CRBD severity will be done upon receiving the patient in the postoperative care unit (PACU) at 0,1, 2, 6, and 24 hours post-surgery.
24-hour postoperative QoR-15 score will be assessed
Patient satisfaction score, Numerical Rating Scale (NRS) pain score, and use of rescue analgesia will be assessed at the PACU.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 92
1.Age 18-65 years 2.ASA-PS I/II 3.Patients undergoing elective TURBT surgeries under general anesthesia.
Patient Refusal to give consent for the study 2.ASA –PS more than 2 3.Patients who are known cases of arrhythmias, heart block, atrial fibrillation or any cardiac dysfunction 4.Severe respiratory diseases 5.Cirrhosis of the liver 6.History of urinary catheter in situ 7.Allergy to lidocaine 8.Allergy to solifenacin.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the incidence and severity of CRBD in patients receiving transurethral lidocaine irrigation compared to those receiving oral Solifenacin prophylaxis and to demonstrate non-inferiority. From start of the surgery to 24 hours after surgery
- Secondary Outcome Measures
Name Time Method The assessment of following factors during post operative period 1.Patient satisfaction score (7-point Global Perceived Effects Scale)
Trial Locations
- Locations (1)
Post Graduate Institute of Medical Education & Research, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Post Graduate Institute of Medical Education & Research, Chandigarh🇮🇳Chandigarh, CHANDIGARH, IndiaDr Keerthana BPrincipal investigator9791978091keerthanabalachandiran@gmail.com