NCT03005665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

December 15, 2016

Last Update Submit

December 24, 2016

Conditions

Intracranial Pressure Increase

Keywords

optic nerve sheath diameteracetazolamide

Outcome Measures

Primary Outcomes (1)

  • Change in Optic nerve sheath diameter being assessed

    optic nerve sheath diameter measured during perioperative period

    baseline, 5 minutes, 10 minutes, 60 minutes, 120 minutes, 5 minutes post surgery

Secondary Outcomes (1)

  • Visual analog score for incision site and shoulder pain

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

Study Arms (2)

Group A - Acetazolamide

EXPERIMENTAL

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

Group s - Normal saline

PLACEBO COMPARATOR

20 ml normal saline total volume.

Drug: Normal Saline

Interventions

AcetazolamideDRUG
Group A - Acetazolamide
Normal SalineDRUG
Group s - Normal saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of either gender
  • years of age
  • Hemodynamically stable patients.

You may not qualify if:

  • Patient's refusal.
  • Ocular Defects/ Wounds /Previous ocular surgery.
  • H/O Hypertension
  • Patients having Double Renal Arteries.
  • Laparoscopic Nephrectomies converted to Open Surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

AcetazolamideSaline Solution

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ThiadiazolesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ashish S Aditya, MD

    PGIMER, chandigarh, INDIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
JUNIOR RESIDENT

Study Record Dates

First Submitted

December 15, 2016

First Posted

December 29, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

December 29, 2016

Record last verified: 2016-12

Locations

IN(1)