Clinical trial NCT03005665: Effect of Acetazolamide on Optic Nerve Sheath Diameter in Laparoscopic Donor Nephrectomies
Official title: Effect of Orogastric Acetazolamide on Intraocular Pressure in Laparoscopic Donor Nephrectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Pressure Increase
Keywords: optic nerve sheath diameter
acetazolamide
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Optic nerve sheath diameter being assessed
timeFrame: baseline, 5 minutes, 10 minutes, 60 minutes, 120 minutes, 5 minutes post surgery
Secondary outcomes:
measure: Visual analog score for incision site and shoulder pain
timeFrame: baseline, 30 minutes, 60 minutes, 4 Hours, 12 hours, 24 Hours, 48 hours, 72 Hours.
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
affiliation: PGIMER, chandigarh, INDIA
name: Ashish S Aditya, MD
role: PRINCIPAL_INVESTIGATOR
References: