Effect of Acetazolamide on Optic Nerve Sheath Diameter in Laparoscopic Donor Nephrectomies

Intracranial Pressure Increase Clinical Trial

Official title:

Effect of Orogastric Acetazolamide on Intraocular Pressure in Laparoscopic Donor Nephrectomies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005665
• Other study ID #: 10055/PG-2Trg/2014/24258-59
• Status: Completed
• Phase: N/A
• First received: December 15, 2016
• Last updated: December 24, 2016
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

The purpose of the trial is to study the effect of acetazolamide administered via Ryle's tube on optic nerve sheath diameter in laparoscopic live donor nephrectomy patients.

Description:

this study was done on 40 American Society of Anaesthesiologist(ASA) I & II live donors of either sex in adult age group undergoing laparoscopic live donor nephrectomy. After getting approval from institutes ethical committee and written informed consent, Donors were randomly allocated to either of two group. Anaesthesia was induced with injection morphine 0.1 mg/kg, injection propofol 1-2 mg/kg and vecuronium 0.1 mg/kg. Maintenance of anaesthesia was done with isoflurane and oxygen. After induction donors were placed into modified flank position with left side upward. Donors in Group A received Acetazolamide 5 mg/kg via orogastric tube soon after the induction of anaesthesia. Group S received saline as a placebo. investigator and subjects were blinded till the statistical analysis. Optic nerve sheath diameter was measured six times during perioperative periods by using high frequency ultrasound probe. Intra operative monitoring was done for Heart rate, Blood Pressure, pulse oximetry(Spo2), End Tidal Carbon Dioxide(ETCO2), Train Of Four(TOF) and Bi spectral index(BIS). Post operatively donors were reversed with injection neostigmine and glycopyrrolate.

once return of spontaneous ventilation was well established and patient becomes conscious oriented trachea was extubated and donors were shifted to post anaesthetic care unit(PACU). Postoperatively donors were monitored for Heart rate, Blood Pressure, Spo2, Comfort Score, Visual analog score for incisional site pain and shoulder tip pain, and Post operative nausea vomiting. Rescue analgesia was given to patients having comfort score less than 6.

After completion of study Optic nerve sheath diameter, pain scores and comfort scores was compared between both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients of either gender

• 18-60 years of age

• Hemodynamically stable patients.

Exclusion Criteria:

• Patient's refusal.

• Ocular Defects/ Wounds /Previous ocular surgery.

• H/O Hypertension

• Patients having Double Renal Arteries.

• Laparoscopic Nephrectomies converted to Open Surgeries

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intracranial Hypertension
• Intracranial Pressure Increase

Intervention

Drug:
• Acetazolamide

• Normal Saline

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Optic nerve sheath diameter being assessed	optic nerve sheath diameter measured during perioperative period	baseline, 5 minutes, 10 minutes, 60 minutes, 120 minutes, 5 minutes post surgery	No
Secondary	Visual analog score for incision site and shoulder pain	visual analog score will be monitored postoperatively	baseline, 30 minutes, 60 minutes, 4 Hours, 12 hours, 24 Hours, 48 hours, 72 Hours.	No