Effect of Acetazolamide on Optic Nerve Sheath Diameter in Laparoscopic Donor Nephrectomies
Primary Purpose
Intracranial Pressure Increase
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Acetazolamide
Normal Saline
Sponsored by
About this trial
This is an interventional prevention trial for Intracranial Pressure Increase focused on measuring optic nerve sheath diameter, acetazolamide
Eligibility Criteria
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
Sites / Locations
- PGIMER
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A - Acetazolamide
Group s - Normal saline
Arm 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.
20 ml normal saline total volume.
Outcomes
Primary Outcome Measures
Change in Optic nerve sheath diameter being assessed
optic nerve sheath diameter measured during perioperative period
Secondary Outcome Measures
Visual analog score for incision site and shoulder pain
visual analog score will be monitored postoperatively
Full Information
NCT ID
NCT03005665
First Posted
December 15, 2016
Last Updated
December 24, 2016
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT03005665
Brief Title
Effect of Acetazolamide on Optic Nerve Sheath Diameter in Laparoscopic Donor Nephrectomies
Official Title
Effect of Orogastric Acetazolamide on Intraocular Pressure in Laparoscopic Donor Nephrectomies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pressure Increase
Keywords
optic nerve sheath diameter, acetazolamide
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A - Acetazolamide
Arm Type
Experimental
Arm 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.
Arm Title
Group s - Normal saline
Arm Type
Placebo Comparator
Arm Description
20 ml normal saline total volume.
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Primary Outcome Measure Information:
Title
Change in Optic nerve sheath diameter being assessed
Description
optic nerve sheath diameter measured during perioperative period
Time Frame
baseline, 5 minutes, 10 minutes, 60 minutes, 120 minutes, 5 minutes post surgery
Secondary Outcome Measure Information:
Title
Visual analog score for incision site and shoulder pain
Description
visual analog score will be monitored postoperatively
Time Frame
baseline, 30 minutes, 60 minutes, 4 Hours, 12 hours, 24 Hours, 48 hours, 72 Hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashish S Aditya, MD
Organizational Affiliation
PGIMER, chandigarh, INDIA
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
Learn more about this trial
Effect of Acetazolamide on Optic Nerve Sheath Diameter in Laparoscopic Donor Nephrectomies
We'll reach out to this number within 24 hrs