A study to compare the procedure of giving small bolus of fluid through vein during surgery on paralyzed patients, ventilated by machine, lying on abdomen for its effect on changes in fluid requirement in two groups, one with disturbed autonomic nervous system and another with intact system.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2019/07/020316
- Lead Sponsor
- DR FAHMEENA BEGUM
- Brief Summary
A Prospective single blinded controlled Observational study will be conducted in 60 patients electively posted for surgery in prone position. Patients will be recruited and divided into 2 groups of 30 each based on the results of bedside clinical tests for autonomic dysfunction which will be performed a day before the surgery while doing the pre-anaesthetic check up. Group 1 : Patients with autonomic dysfunction. Group 2 : Patients without autonomic dysfunction. Intra-operatively these patients will be subjected to a fluid bolus of 6% Hydroxyethyl starch and SPV changes (Systolic pressure variation -- dynamic index for fluid therapy) will be monitored along with continuous monitoring of Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Blood Pressure (MAP) and ECG. The study focuses on comparison of SPV changes in response to intravenous fluid bolus between patients with autonomic dysfunction and patients without autonomic dysfunction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- Age between 18 to 60 years.
- Either sex 3.
- ASA I and II 4.
- Scheduled for prone position surgery.
- Patients who are not willing to participate.
- Patients who are unable to perform bed side autonomic dysfunction tests.
- Patients with abnormal renal function tests and hepatic function tests.
- Patients with raised baseline and intraoperative blood pressures.
- Those patients who needed vasoactive drugs during surgery to maintain hemodynamic stability.
- Patients with Cardiac or Respiratory compromise.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare intraoperative fluid responsiveness (SPV changes) in mechanically ventilated patients in prone position with and without autonomic dysfunction. During the surgery
- Secondary Outcome Measures
Name Time Method To compare changes in Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP) in mechanically ventilated patients in prone position with and without autonomic dysfunction. During the surgery
Trial Locations
- Locations (1)
NIZAMS INSTITUTE OF MEDICAL SCIENCES, HYDERABAD
🇮🇳Hyderabad, TELANGANA, India
NIZAMS INSTITUTE OF MEDICAL SCIENCES, HYDERABAD🇮🇳Hyderabad, TELANGANA, IndiaDR FAHMEENA BEGUMPrincipal investigator9573633765fahmeena27@gmail.com