NCT02818530

Brief Summary

Intra ocular pressure (IOP) may theoretically increase due to steep Trendelenberg position and studies showed that IOP reaches peak levels after steep Trendelenberg position on an average of 13 mmHg higher than preanesthesia induction values. Major determinants of IOP are aqueous humor flow, choroidal blood volume, central venous pressure and extra ocular muscle tone. Hassen GW et al measured anterior chamber depth in 2 patients with glaucoma and compared the anterior chamber depth (ACD) with the intraocular pressure measured by tonometer. They concluded that bedside ultrasound could be useful in evaluating patient with suspected increased IOP, who are unable to open their eyes.

Trial Health

57
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Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

June 21, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2018

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

June 18, 2016

Last Update Submit

May 8, 2018

Conditions

Urological CancerGastrointestinal CancerMalignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (2)

  • Changes in intraocular pressure measured by tonometer

    Intra operative recordings of IOP will be after induction and thereafter will be measured every 2 hours and at the end of surgery.

    Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery

  • Changes in anterior chamber depth measured by ultrasound.

    Intra operative recordings of anterior chamber depth will be measured after induction of anaesthesia, every 2 hours intraoperatively and at end of surgery.

    Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery

Secondary Outcomes (2)

  • Time dependent changes in IOP during prolonged steep Trendelenberg position.

    Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery

  • Time dependent changes in anterior chamber depth during prolonged trendelenberg position.

    Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery

Study Arms (1)

IOP by tomoneter and ultrasound

EXPERIMENTAL

Intraocular pressure will be measured by electronic tomometer (tonopen) at different point of time after induction of anaesthesia in patients undergoing robotic assisted surgery under steep Trendelenberg position. Anterior chamber depth will be measured by ultrasound at the same time intervals.

Device: IOP by tonometerDevice: Anterior chamber depth measurement by ultrasound

Interventions

IOP by tonometerDEVICE

Electronic tonometer will be used as gold standard for intraocular pressure measurement in supine position after induction of anaesthesia and every 2 hours intraoperatively and at end of surgery.

IOP by tomoneter and ultrasound
Anterior chamber depth measurement by ultrasoundDEVICE

Anterior chamber depth will be measured by ultrasound in supine position after induction of anaesthesia and every 2 hours intraoperatively and at end of surgery.

IOP by tomoneter and ultrasound

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class I-III
  • Urological cancer patients under going robotic assisted surgeries.
  • Gastrointestinal cancer patients under going robotic assisted surgeries,
  • Gynecological cancer patients under going robotic assisted surgeries,

You may not qualify if:

  • ASA class IV and above
  • Patients with a history of glaucoma.
  • Patients with corneal disease, retinal vascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohan Lal solanki

Mumbai, Maharashtra, 400088, India

Location

MeSH Terms

Conditions

Urologic NeoplasmsGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Sohan L Solanki, MD

    Tata Memorial Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Anesthesiology, Critical Care and Pain

Study Record Dates

First Submitted

June 18, 2016

First Posted

June 29, 2016

Study Start

June 21, 2017

Primary Completion

May 7, 2018

Study Completion

May 7, 2018

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

IN(1)