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

Not Applicable

Completed

• Conditions: Intracranial Pressure Increase
• Interventions: Drug: Normal Saline; Drug: Acetazolamide

• Registration Number: NCT03005665
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2016-10
• Status Verified: 2016-12
• Study Completion: 2016-12
• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-24
• Last Update Submitted: 2016-12-24
• Study First Posted: 2016-12-29
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group s - Normal saline	Normal Saline	20 ml normal saline total volume.
Group A - Acetazolamide	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.

Primary Outcome Measures

Name	Time	Method
Change in Optic nerve sheath diameter being assessed	baseline, 5 minutes, 10 minutes, 60 minutes, 120 minutes, 5 minutes post surgery	optic nerve sheath diameter measured during perioperative period

Secondary Outcome Measures

Name	Time	Method
Visual analog score for incision site and shoulder pain	baseline, 30 minutes, 60 minutes, 4 Hours, 12 hours, 24 Hours, 48 hours, 72 Hours.	visual analog score will be monitored postoperatively

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, India