Clinical trial NCT02818530: Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound
Official title: Correlation Between Intraocular Pressure Measurement by Tomometer and Anterior Chamber Depth Measurement by Ultrasound in Steep Trendelenberg Position During Robotic Assisted Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urological Cancer
Gastrointestinal Cancer
Malignant Female Reproductive System Neoplasm
Lead sponsor: Tata Memorial Centre
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in intraocular pressure measured by tonometer
timeFrame: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
measure: Changes in anterior chamber depth measured by ultrasound.
timeFrame: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Secondary outcomes:
measure: Time dependent changes in IOP during prolonged steep Trendelenberg position.
timeFrame: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
measure: Time dependent changes in anterior chamber depth during prolonged trendelenberg position.
timeFrame: Just after induction of anesthesia, every 2 hours during surgery and immediately after surgery
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Sohan Lal solanki
state: Maharashtra
Study officials:
affiliation: Tata Memorial Centre
name: Sohan L Solanki, MD
role: PRINCIPAL_INVESTIGATOR
References: