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

NCT ID: NCT03005665

Last Updated: 2016-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Intracranial Pressure Increase

Keywords

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optic nerve sheath diameter acetazolamide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Acetazolamide

Intervention Type DRUG

Group s - Normal saline

20 ml normal saline total volume.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Interventions

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Acetazolamide

Intervention Type DRUG

Normal Saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ashish Singh Aditya

JUNIOR RESIDENT

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashish S Aditya, MD

Role: PRINCIPAL_INVESTIGATOR

PGIMER, chandigarh, INDIA

Locations

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PGIMER

Chandigarh, Chandigarh, India

Site Status

Countries

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India

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id