Optic Nerve Sheath Diameter using ultrasound for indirect assessment of intracranial pressure in laparoscopic cholecystectomy patients following intubation or insertion of I-Gel

Phase 4

Not yet recruiting

• Conditions: Calculus of gallbladder and bile duct without cholecystitis,

• Registration Number: CTRI/2023/05/052985
• Lead Sponsor: Dr RPGMC Kangra at Tanda

Brief Summary

Laparoscopic cholecystectomy is the gold standard for gallstone and gallbladder diseases. After pneumoperitoneum, changes maybe observed in intrathoracic, intraabdominal, intracranial pressures. To measure intracranial pressure technique like orbital sonography with optic nerve sheath diameter measurement has been developed.  This trial is ’evaluation and comparison of the Optic Nerve Sheath Diameter (ONSD) assessed by ultrasound following tracheal intubation or insertion of I-Gel’. We will include the patients aged from 25 to 60 years of either sex with gall stone disease undergoing laparoscopic cholecystectomy under general anesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-06
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients between the age group 25 to 60 years 2.
• ASA class 1-2 3.
• BMI 18.5-29.9 kg/m2 4.
• Mallampati 1 or 2.

Exclusion Criteria

• Patients with Severe Cardiovascular or Respiratory disorders, Diabetes, Hypertension 2.
• Obesity (BMI>30kg/m2) 3.
• Difficult airway 4.
• History of sleep apnea 5.
• Eye surgery, Orbital trauma 6.
• Anticipated duration of surgery >2 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in ONSD	T0- before induction of anesthesia, T1- 5 min after intubation/Igel insertion in supine position, T2- 10 min post pneumoperitoneum, T3- 10 min after 30 degree reverse Trendelenburg positioning, T4- pneumoperitoneum and reverse Trendelenburg, T5- 5 min after supine position without pneumoperitoneum

Secondary Outcome Measures

Name	Time	Method
postoperative nausea and vomiting	24 hours after surgery
Heart Rate, Mean arterial blood pressure, Peak airway pressure, EtCO2	as in primary outcome

Trial Locations

Locations (1)

Dr RPGMC Kangra at Tanda; 🇮🇳 Kangra, HIMACHAL PRADESH, India

Dr RPGMC Kangra at Tanda

🇮🇳Kangra, HIMACHAL PRADESH, India

Neeru

Principal investigator

9729405510

neer5897@gmail.com