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

Effect of Orogastric Acetazolamide on Intraocular Pressure in Laparoscopic Donor Nephrectomies

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Pressure Increase
• Intervention / Treatment: Drug: Normal Saline; Drug: Acetazolamide

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A - Acetazolamide; Acetazolamide 5 mg/kg diluted in 10 ml normal saline through orogastric Ryle's Tube soon after the induction of anaesthesia followed by 10 ml normal saline flush.	Drug: Acetazolamide
PLACEBO_COMPARATOR: Group s - Normal saline; 20 ml normal saline total volume.	Drug: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research
• Investigators: Principal Investigator: Ashish S Aditya, MD, PGIMER, Chandigarh, India

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: December 24, 2016
• First Posted (ESTIMATE): December 29, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 29, 2016
• Last Update Submitted That Met QC Criteria: December 24, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: acetazolamide; optic nerve sheath diameter
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Diuretics; Anticonvulsants; Acetazolamide
• Other Study ID Numbers: 10055/PG-2Trg/2014/24258-59