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

P

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Completed

Conditions

Intracranial Pressure Increase

Treatments

Drug: Acetazolamide
Drug: Normal Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03005665
10055/PG-2Trg/2014/24258-59

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups, including a placebo group

Group A - Acetazolamide
Experimental group
Description:
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.
Treatment:
Drug: Acetazolamide
Group s - Normal saline
Placebo Comparator group
Description:
20 ml normal saline total volume.
Treatment:
Drug: Normal Saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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