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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02818530
Other study ID # PN 1690
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 21, 2017
Est. completion date May 7, 2018

Study information

Verified date May 2018
Source Tata Memorial Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. During the robotic surgery there are two theories explaining the increase of IOP, first, gravitational forces increase central venous pressure which in turn affect orbital venous pressure and increase IOP. Second, intraperitoneal carbon dioxide causes increased choroidal blood volume which may result in IOP increase. One study reported that low end tidal carbon dioxide was a significant predictor of the IOP increase. Continuous absorption of carbon dioxide from peritoneum and increased pressure on diaphragm results in lower delivered tidal volumes and subsequently increased arterial carbon dioxide levels leading to increased choroidal blood flow and increased IOP.

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. It can also be used for serial examination and follow-up of treatment success. They also mentioned that, it is necessary to conduct a prospective study with a larger sample size, to evaluate if there is agreement between measurements using a tonometer and measurements of the ACD using ultrasound. In addition, it is essential to determine the cut off normal ACD for evaluation of IOP.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date May 7, 2018
Est. primary completion date May 7, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. ASA class I-III

2. Urological cancer patients under going robotic assisted surgeries.

3. Gastrointestinal cancer patients under going robotic assisted surgeries,

4. Gynecological cancer patients under going robotic assisted surgeries,

Exclusion Criteria:

1. ASA class IV and above

2. Patients with a history of glaucoma.

3. Patients with corneal disease, retinal vascular disease.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
IOP by tonometer
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.
Anterior chamber depth measurement by ultrasound
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.

Locations

Country Name City State
India Sohan Lal solanki Mumbai Maharashtra

Sponsors (1)

Lead Sponsor Collaborator
Tata Memorial Centre

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Time dependent changes in IOP during prolonged steep Trendelenberg position. Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Secondary 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
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