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Study the effect of drug on awakening time of patient and its quality after completion of surgery

The effect of Aminophylline on Bispectral Index and clinincal recovery characteristics in patients undergoing laparoscopic cholecystectomy under general anaesthesia â?? A randominzed placebo controlled double blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013679
Enrollment
100
Registered
2018-05-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- cholithiasis for laparoscopic cholesystectomy

Interventions

Intervention1: Aminophylline 3mg/kg IV at the end of surgery: aminophylline drug compared with normal saline to study its effect on extubation time, clinical recovery characteristics and its effect on

Sponsors

SGRDIMSAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I and II Either sex Scheduled for laparoscopic cholecystectomy under GA

Exclusion criteria

Exclusion criteria: ASA III and above Major hepatic, renal or cardiovascular dysfunction Pregnancy Hypersensitivity to aminophylline or other methylxanthines Chronic therapy with aminophylline or other methylxanthines (to avoid toxic drug levels). Uncontrolled hypertension and myocardial disease Patient on following drugs- Macrolides, Calcium channel blockers, Cimetidine, Quinolones, Rifampicin, Carbamazepine, Lithium, Phenytoin. Chronic smokers

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of aminophylline and placebo on BIS scores in patients under isoflurane anaesthesia and to correlate it with clinical recovery charcteristics. To compare the effect of aminophylline vs placebo on clinical recovery characteristics in patients undergoing laparoscopic cholecystectomy under isoflurane anaesthesia Timepoint: clinical recovery charcteristics and heminodynaminc varibles at removal of laparoscpe and every minute thereafter till extubation.

Secondary

MeasureTime frame
intraoperative and postoperative hemodymaic stability and postoerative cognitive effect on patientTimepoint: intraoperative and upto 24 hour after surgery

Countries

India

Contacts

Public ContactDr Sunil Chawla

Sri Guru Ram das institute of Medical Sciences And Research

dr.amritpalsingh85@gmail.com9646921949

Outcome results

None listed

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