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Comparison of postoperative lung functions and outcomes of general anaesthesia with regional anaesthesia versus regional anaesthesia alone in patients undergoing major open abdominal surgeries: an exploratory randomized study

Comparison of postoperative pulmonary functions and outcomes in patients undergoing major open abdominal surgeries between general anaesthesia with thoracic epidural and thoracic continuous spinal anaesthesia: an exploratory randomized study - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062705
Enrollment
60
Registered
2024-02-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Thoracic Continuous Spinal Anaesthesia: Continuous spinal catheter of 24G or 25G will be inserted in T9 andT10 intervertebral space and 0.5mL bolus doses of isobaric levobupivacaine 0.5

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18years Both genders ASA physical status I-III Patient undergoing Elective major abdominal surgery

Exclusion criteria

Exclusion criteria: Refusal by the patient Any contraindication to Thoracic Epidural Anaesthesia and Thoracic Continuous Spinal Anaesthesia Emergency surgery Abdominal trauma patient Expected severe hemodynamic instability (pheochromocytoma) Pregnant females BMI more than 35 Severe systemic disease (ASA physical status IV)

Design outcomes

Primary

MeasureTime frame
To compare the peak expiratory flow rate assessed using hand held spirometer at predefined time pointsTimepoint: preoperative (T0) immediate postoperative (T1) post operative day 1 (T2) post operative day 2 (T3) post operative day 3 (T4)—

Secondary

MeasureTime frame
To compare all cause in-hospital mortality in patients receiving general anaesthesia plus thoracic epidural versus thoracic continuous spinal anaesthesiaTimepoint: throughout the hospital stay of the patient;To compare breath holding time and SpO2 at predefined time pointsTimepoint: preoperative (T0) immediate postoperative (T1) post operative day 1 (T2) post operative day 2 (T3) post operative day 3 (T4);To compare postoperative change in trans-diaphragmatic excursion (ultrasound assessed Delta TDI) at predefined time pointsTimepoint: preoperative (T0) immediate postoperative (T1) post operative day 1 (T2) post operative day 2 (T3) post operative day 3 (T4);To compare the incidence of other postoperative pulmonary complications (pleural effusion, pneumonia, pneumothorax, acute respiratory distress syndrome)Timepoint: preoperative (T0) immediate postoperative (T1) post operative day 1 (T2) post operative day 2 (T3) post operative day 3 (T4);To compare the incidence of postoperative lung atelectasis (ultrasound assessed) at predefined time pointsTimepoint: preoperative (T0) immediate postoperative (T1) post operative day 1 (T2) post operative day 2 (T3) post operative day 3 (T4)—

Countries

India

Contacts

Public ContactDr Praveen Talawar

AIIMS Rishikesh

praveenrt64@gmail.com9654162941

Outcome results

None listed

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