Status:
COMPLETED
Effect of Preoperative Music on Sterile Inflammation Induced by Laparoscopic Surgery
Lead Sponsor:
Sir Ganga Ram Hospital
Conditions:
Music Therapy
Cholecystitis/Cholelithiasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Surgery induced sterile inflammation leaves behind a biomolecular footprint measurable by various pro-inflammatory markers e.g. IL-6, CD(Cluster of differentiation)19B, HsCRP(High-sensitivity CRP) etc...
Detailed Description
INTRODUCTION Historically, surgery was seen as the last resort to preserve life. Even today, the popular acceptance of surgery is premised upon it being either as the only treatment option or as the l...
Eligibility Criteria
Inclusion
- Age more than 18 years.
- Should be able to understand and sign an informed consent.
- Consent for surgery, anaesthesia and the use of standardized music before surgery. (Appendix I)
- Fitness for General Anesthesia (GA)
- Ability to maintain \& communicate a PRO diary.
- Ability to communicate via telephone or email or SMS or WhatsApp.
Exclusion
- Fitfor GA but higher than ASA Grade I.
- Uncontrolled coagulopathy
- Suspicion of carcinoma gallbladder on USG
- Any suspicion of common bile duct (CBD) stones or pancreatitis.
- Patient using chronic anti-inflammatory drug.
- Concomitant common bile duct (CBD) stone or any CBD intervention/pancreatitis in the preceding 6 weeks.
- Patient on immunosuppressive / cytotoxic/ steroid therapy.
- Documented or known sensitivity to any drug to be used in the study protocol.
- Pregnant or lactating ladies.
- Any concomitant surgery
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03429478
Start Date
November 1 2017
End Date
December 1 2019
Last Update
December 27 2019
Active Locations (1)
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1
Prof. Brij Bushan Agarwal
Delhi, India, 110058