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Comparison of three anaesthesia medication combinations given through the epidural route (in the space surrounding the spinal cord) regarding their ability to influence blood pressure during surgery in patients undergoing open surgery for ovarian cancer.

Intra-operative hypotension with three different epidural regimens in patients undergoing laparotomy for Carcinoma Ovary- a pilot study for a randomised controlled trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069399
Enrollment
45
Registered
2024-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: C569- Malignant neoplasm of unspecifiedovary

Interventions

Intervention1: Bupivacaine,Morphine: Epidural Bupivacaine infusion 0.1% at 4ml/hour plus single epidural morphine bolus 50mcg/kg ideal body weight from laparotomy incision till end of surgery Control

Sponsors

Dr Nairita Das
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Age greater than 18 years 2)Carcinoma Ovary patients posted for elective open staging laparotomy 3)ASA (American Society of Anaesthesiologists) physical status 1,2 and 3 patients.

Exclusion criteria

Exclusion criteria: 1.Patients not consenting/contraindication to epidural. 2.ASA4 and above patients. 3.Low preoperative BP (systolic BP less than 100mmHg) either during pre-medication visit or the baseline vitals on shifting to operating theatre. 4.Patients with low ejection fraction (less than 50%) and/or regional wall motion abnormalities. 5.Patients declared inoperable after diagnostic laparoscopy. 6.Patients with allergy to any of the study drugs 7.Patients with severe or massive ascitis or in obstruction. 8.Patients with a low preoperative BMI less than 18.5 kg/m2. 9.Patients with marked hypoalbuminemia (Serum albumin less than 2.5 g/dL) 10. Any emergency surgeries.

Design outcomes

Primary

MeasureTime frame
1. Number of episodes of intraoperative hypotension (defined as mean arterial blood pressure less than 70 mmHg) from the time of laparotomy incision to two hours from laparotomy incision. 2. Mean of the mean arterial blood pressure (in mmHg) during these intra-operative hypotension episodes from laparotomy incision to two hours from laparotomy incision. Timepoint: Starting point of measurement: Time of laparotomy incision End point of measurement: two hours from the point of laparotomy incision

Secondary

MeasureTime frame
Maximum dose of noradrenaline requirement in mcg/kg/min to treat Intraoperative hypotension and duration of Noradrenaline requirement.Timepoint: From laparotomy incision to two hours from laparotomy incision. ;Total dose of ephedrine in milligrams and/or phenylephrine in micrograms to treat this Intraoperative hypotensionTimepoint: From laparotomy incision to two hours from laparotomy incision.

Countries

India

Contacts

Public ContactDr Aravind Narayanan

Cancer Institute (WIA) Adyar, Chennai

nairita1987@gmail.com9940656437

Outcome results

None listed

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