Comparison 0f Effects of two different doses of oral drug tapentadol to prevent urinary catheter related urinary bladder discomfort in patients undergoing routine surgeries under general anaesthesia in Tertiary Hospital

Effects Of Two Different Doses Of Pre-Emptive Oral Tapentadol for Attenuation Of Catheter Related Bladder Discomfort In Patient Undergoing Elective Surgeries under General Anaesthesia: A Double Blind Randomised Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071318

Enrollment

100

Registered

2024-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Tablet Tapentadol 75 mg: Group A will receive oral tapentadol 75 mg , patients schedule for elective surgeries,inwhich urinary catheterisation is supposed to maintained for more than 24

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patiens between the ages of 18 to 60 years of either sex 2.Body mass index between 18.9 to 29.9 kg/m2 3.American Society of Anaesthesiologist Grade 1 and 2 3.Elective surgeries under General Anaesthesia requiring urinary catheterization for more than 24 hours.

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2.Known allegy to drug 3.Opioids tolerance/dependence 4.Renal/hepatic impairment 5.Known cardiovascular disease 6.known respiratory impairment like asthma 7.Intestinal obstruction 8.Pregnant and breastfeading woman 9.Urethral surgeries or pathology 10.Catheterisation done in more than 1 attempt or trauma caused during catheterisation

Design outcomes

Primary

Measure	Time frame
PRIMARY OBJECTIVE are 1.To compare the efficacy of two different doses of Tapentadol for attenuation of Catheter related bladder discomfortTimepoint: 1 day	—

Secondary

Measure	Time frame
SECONDARY OBJECTIVES are 1.To compare surgical sress response 2.To study hemodynamic variable of patient 3.To compare post operative Nausea and VomitingTimepoint: 1 day	—

Countries

India

Contacts

Public ContactDr Amit Kumar Singh

Uttar pradesh university of medical sciences, saifai

dramit2212@gmail.com7351768859

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026