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Comparing Hemodynamic Stress Responses: Conventional Awake Extubation vs. I-Gel Exchange Extubation in Craniotomy Surgeries

A Randomized Study To Compare The Hemodynamic Stress Response Between Conventional Awake Extubation Of Endotracheal Tube And I-GEL Exchange Extubation During Emergence From General Anaesthesia In Craniotomy Surgeries - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084319
Enrollment
70
Registered
2025-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: G939- Disorder of brain, unspecified Health Condition 2: G94- Other disorders of brain in diseases classified elsewhere

Interventions

Intervention1: Conventional Awake Extubation of Endotracheal Tube: After completion of craniotomy surgery under general anaesthesia ,patient is extubated in the conventional manner. Intervention2: I-G

Sponsors

Rukmani Birla Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: With consent for the procedure, ASA grade 1 & 2,Age group 18 to 60 years,Modified Mallampati grade 1 and 2, Undergoing general anaesthesia for elective craniotomy surgeries,Tumor size less than 4cm,Aneurysm,Modified Fischer grade 1 or 2,Surgical duration less than 4 hours,Blood loss less than 400ml,Fasting greater than or equal to 8 hours,BMI less than 30

Exclusion criteria

Exclusion criteria: Refusal to give consent,History of allergic drug reaction to any of the proposed drugs set to be used during the procedure,Patients with anticipated difficult intubation,Glasgow coma score less than 15, ASA grade 3,4 and 5, Patients with signs of increased ICP Volumes greater than 1.5ml per kg on ultrasound guided gastric antrum examination, History of congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus, acute respiratory distress syndrome, psychiatric illness, bleeding disorder, hepatic or renal dysfunction Patients who may need elective mechanical ventilation post operatively Patients who are receiving IV beta blockers Pregnancy

Design outcomes

Primary

MeasureTime frame
The change in Heart Rate,Systolic Blood Pressure, Diastolic Blood Pressure and Mean Arterial Blood Pressure.Timepoint: The parametres were measured At the end of surgery, After reversal, 1 minute after reversal, 3 minutes after reversal, 5 minutes after reversal, 10 minutes after reversal, 15 minutes after reversal,1 hour post operatively and 6 hours post operatively.

Secondary

MeasureTime frame
To compare the total doses of intravenous Diltiazem required in each group to maintain hemodynamic parameters (Heart Rate & Mean Arterial Pressure) within 20% of baseline values during the extubation period. To evaluate the incidence of respiratory complications following withdrawal of general anaesthesia, such as bucking, coughing, desaturation, laryngospasm, & pulmonary edema.Timepoint: Intravenous Diltiazem will be administered At the end of surgery, after reversal, 1 minute after reversal,3 minutes after reversal, 5 minutes after reversal, 10 minutes after reversal & 15 minutes after reversal.

Countries

India

Contacts

Public ContactDR HUDA SUBAIR

RUKMANI BIRLA HOSPITAL, A UNIT OF CMRI , JAIPUR

drruchibaid@gmail.com9828119109

Outcome results

None listed

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