The study to show factors affecting early recovery after surgery including fluid management

Phase 1

Not yet recruiting

Conditions: Other intraoperative and postprocedural complications and disorders of digestive system,

Registration Number: CTRI/2020/03/024318

Lead Sponsor: DrSandeep Sahu

Brief Summary: Fluid balance is a major contributing factor to postoperative morbidity and mortality. Persistant hypovolemia is associated with organ hypoperfusion,systemic inflammatory response syndrome,sepsis and multiple organ failure. Fluid overload, on the other hand, is associated with edema , ileus, postoperative nausea and vomiting, pulmonary complications and increased cardiac demand. Our aim is to demonstrate that a low volume fluid management strategy does not adversely affect outcome and also to apply enhance recovery program to the patients undergoing major abdominal surgeries to improve the overall outcome by decreasing the fasting duration by giving a carbohydrate load 2 hrs prior to surgery, adequate analgesia preferably non narcotic analgesia, adequate control of PONV and to study and compare the pain scores, hospital stay and any associated complications. Enhanced recovery programs were initially formulated for various GI surgeries and later applied to various other surgeries. After taking written and informed consent from the patient, this study would be conducted in adult patients ( >18 and found fit for surgery), irrespective of gender, undergoing major abdominal surgeries. The intraoperative fluid requirement with a guided fluid therapy and the postoperative pain scores, incidence of nausea-vomiting, incidence of PONV and perioperative complications will be studied in comparison with a standard operative care group.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients willing to participate Pt age: > 18 yrs and found fit for major abdominal surgery ASA 1 and 2 Patients undergoing major abdominal surgeries including Whippleâ€™s procedure Colorectal surgeries.

Exclusion Criteria

Patientâ€™s refusal to participate Patients with severe, persistent peripheral vasoconstriction or arterial spasm, such as in shock states Device related exclusion criteria : Patients of dilated cardiomyopathy with left ventricular ejection fraction less than 40% Patients with artificial hearts and ventricular assist devices (VAD).
Patients with severe, persistent arrhythmias.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study and compare the postoperative length of stay in postop ICU in SGPGI Early Recovery Program (SERP) group utilising goal directed fluid therapy (by FloTrac/Vigileo ,SVV guided fluid therapy ) with standard therapy group utilising CVP based intraoperative fluid management.	24 hrs

Secondary Outcome Measures

Name	Time	Method
To study and compare the intraoperative fluid requirement in the SERP(SVV) and standard therapy group(CVP). (total fluid given, bolus given, ml/kg body wt. fluid in both groups).	To compare the intraoperative hemodynamics in both group.

Trial Locations

Locations (1): Sanjay Gandhi Postgraduate institute
🇮🇳
Lucknow, UTTAR PRADESH, India
Sanjay Gandhi Postgraduate institute
🇮🇳Lucknow, UTTAR PRADESH, India
DrSandeep Sahu
Principal investigator
8004904598
drsandeepsahu09@gmail.com