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Completed

NCT Number: NCT03005665

Effect of Acetazolamide on Optic Nerve Sheath Diameter 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PGIMER

Chandigarh, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetazolamide

Drug

normal saline

Drug

Primary outcomes

  1. Change in Optic nerve sheath diameter being assessed

    Time frame: baseline, 5 minutes, 10 minutes, 60 minutes, 120 minutes, 5 minutes post surgery

    optic nerve sheath diameter measured during perioperative period

Secondary outcomes

  1. Visual analog score for incision site and shoulder pain

    Time frame: baseline, 30 minutes, 60 minutes, 4 Hours, 12 hours, 24 Hours, 48 hours, 72 Hours.

    visual analog score will be monitored postoperatively

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

Effect of Orogastric Acetazolamide on Intraocular Pressure in Laparoscopic Donor Nephrectomies

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 29, 2016
Registry last updated
Dec 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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