A Clinical Trial to Compare And Study The Effects Of Enhanced Recovery After Surgery (ERAS) Protocol Vs Conventional Care In Patients Undergoing surgery For Brain Aneurysm

Completed

• Conditions: Nontraumatic subarachnoid hemorrhage, unspecified, (2) ICD-10 Condition: I671||Cerebral aneurysm, nonruptured,

• Registration Number: CTRI/2021/10/037409
• Lead Sponsor: All india institute of medical sciences

Brief Summary

This study is a randomized control trial, single center study comparing the efficacy of enhanced recovery after surgery (ERAS) protocol vs conventional care in 46 patients who will be undergoing elective craniotomy for intracranial aneurysm  that will be conducted in neurosciences centre , All India institute of medical sciences, New Delhi. The primary outcome measures will be length of stay in hospital. Secondary outcomes will be Intraoperative fentanyl consumption, Postoperative pain assessment by Numerical Rating Score (NRS) pain score every 2 hours for 24 hours, Postoperative analgesic requirement in 24 hours, Postoperative antiemetic requirement in 24 hours, Length of ICU stay, Any Complications (surgical and non-surgical) till discharge, Functional recovery at discharge,1month and 3 months and Patient satisfaction score at discharge

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-31
• Study Completion: 2023-06-30
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1.Patient who gives Informed Consent 2.Patients with anterior circulation aneurysms with World Federation of Neurosurgical Societies(WFNS) grade 1 3.ASA grade 1 and 2 4.GCS 15/15.

Exclusion Criteria

1.Patients not giving consent 2.Patients with posterior circulation aneurysm 3.World Federation of Neurosurgical Societies (WFNS) grade 2,3,4 and 5 4.Age less than 18 years and more than 65 years 5.ASA grade 3,4,5 6.Pregnant patients 7.Patient requiring postoperative ventilation 8.History of previous brain surgery 9.Preoperative cognitive dysfunction 10.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
length of stay in hospital	at discharge

Secondary Outcome Measures

Name	Time	Method
Functional recovery	discharge,1 month and 3 months
Patient satisfaction score	discharge
postoperative complications both surgical(surgical site infection, intracranial infection, epilepsy, haemorrhage, rebleeding , vasospasm etc) and non-surgical complications (respiratory complications, cardiovascular complications gastrointestinal complications, urinary tract complications, and venous thromboembolism etc )	at discharge
Antiemetic requirement in 24 hours	In Postoperative period at 24 hours
Length of ICU stay	duration of stay in ICU after surgery
Fentanyl consumption
Pain assessment by Numerical Rating Score (NRS) pain score	In Postoperative period at every 2 hour interval for 24 hours
Analgesic requirement	In Postoperative period at 24 hours

Trial Locations

Locations (1)

All India Institute Of Medical Sciences; 🇮🇳 South, DELHI, India

All India Institute Of Medical Sciences

🇮🇳South, DELHI, India

Dr Pandit Sneha Amar

Principal investigator

8447164004

snehadocuments2017@gmail.com