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

Sponsor

Postgraduate Institute of Medical Education and Research (Other)

Overall Status

Completed

CT.gov ID

NCT03005665

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Pressure Increase	Drug: Acetazolamide Drug: Normal Saline	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Effect of Orogastric Acetazolamide on Intraocular Pressure in Laparoscopic Donor Nephrectomies

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PGIMER	Chandigarh		India	160012

Sponsors and Collaborators

Postgraduate Institute of Medical Education and Research

Investigators

Principal Investigator: Ashish S Aditya, MD, PGIMER, chandigarh, INDIA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Ashish Singh Aditya, JUNIOR RESIDENT, Postgraduate Institute of Medical Education and Research

ClinicalTrials.gov Identifier:

NCT03005665

Other Study ID Numbers:

10055/PG-2Trg/2014/24258-59

First Posted:

Dec 29, 2016

Last Update Posted:

Dec 29, 2016

Last Verified:

Dec 1, 2016

Keywords provided by Dr. Ashish Singh Aditya, JUNIOR RESIDENT, Postgraduate Institute of Medical Education and Research

optic nerve sheath diameter

acetazolamide

Additional relevant MeSH terms:

Intracranial Hypertension

Acetazolamide

Study Results

No Results Posted as of Dec 29, 2016