Evaluation of Effect on the heart function of patients with Heart disease following insufflation of Carbon di Oxide into the abdomen for the conduct of laparoscopic gall bladder removal surgery

Not yet recruiting

• Conditions: Disorders of gallbladder, biliary tract and pancreas, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (3) ICD-10 Condition: I519||Heart disease, unspecified,

• Registration Number: CTRI/2019/06/019791
• Lead Sponsor: Department of Anesthesia PGIMER

Brief Summary

The present study shall be an open label cohort observational study. Patients with moderate to severe left ventricular dysfunction undergoing laparoscopic cholecystectomy shall be monitored with advance hemodynamic monitors like Flotrac and transthoracic echocardiography to study the effect of pneumoperitoneum on the hemodynamics. Consecutive ASA 1 patients shall also be studied for effect on hemodynamics following creation of pneumoperitoneum.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-07
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Patient planned for laproscopic cholecystectomy 2.Consent to participation 3.Age 18 to 65 years 4.Patient with echocardiography findings consistent with presence of moderate to severe left ventricular dysfunction for the study group.

Exclusion Criteria

1.BMI >35kg/m2 2.Coexisting stenotic valve lesion or right ventricular dysfunction 3.presence of electrcardiographic finding of arrhythmia 4.NYHA 1V physical status 5.End stage hepatic/renal/pulmonary disease.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of effect of pneumoperitoneum on CO and CI in patients with moderate to severe left ventricular dysfunction.	All study parameters shall be recorded at the following time points. Pre-induction (T1), 10 minute after induction (T2), when pneumoperitoneum with intra-abdominal (IAP) pressure of 12mm Hg is achieved (T3), 10 minute after reverse Trendelenburg position(T4), 10 minute after deflation of pneumoperitoneum (T5).

Secondary Outcome Measures

Name	Time	Method
Comparison of effect of pneumoperitoneum on hemodynamic parameters and cardiac function in patients with and without cardiac disease.	All study parameters shall be recorded at the following time points. Pre-induction (T1), 10 minute after induction (T2), when pneumoperitoneum with intra-abdominal (IAP) pressure of 12mm Hg is achieved (T3), 10 minute after reverse Trendelenburg position(T4), 10 minute after deflation of pneumoperitoneum (T5).

Trial Locations

Locations (1)

PGIMER CHANDIGARH; 🇮🇳 Chandigarh, CHANDIGARH, India

PGIMER CHANDIGARH

🇮🇳Chandigarh, CHANDIGARH, India

Versha

Principal investigator

6283049894

varshasapehia@gmail.com