Effect of Acetazolamide on Intraocular Pressure After Being in the Trendelenburg Position.

NCT ID: NCT03107429

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2015-10-01

Brief Summary

Perioperative vision loss following laparoscopic colorectal surgery is rare but has been reported. Studies show Trendelenburg positioning during surgery can produce a significant rise in the IOP, and this rise is thought to be a possible factor. Acetazolamide decreases IOP by reducing the formation of aqueous humour.

Aims:

To investigate if acetazolamide reduces the IOP rise resulting from Trendelenburg positioning.

Methods:

A randomised cross-over blinded pilot study. Nine healthy volunteers were randomised to start with the placebo or Acetazolamide with a 5 days' washout period. Baseline IOP was measured on both days. After 1.5 hours of taking the medication, volunteers lay head-down at 17 degrees' for 4 hours and IOP measurements repeated. This reading was subtracted from the baseline to give a 'change in IOP'.

Detailed Description

Background:

Laparoscopic (keyhole) bowel surgery often requires positioning patients on the operating table in very steeply angled positions for up to four or more hours. There have been case reports of patients suffering cognitive impairment after surgery with long periods of Trendelenburg (person is lying flat at an incline where their head lies lower than their feet) positioning.

Evidence from other fields of surgery suggests that "head-down" positions can produce a significant rise in the intraocular pressure. Transient vision problems and loss of sight has been reported following surgery is rare instances, including one case after laparoscopic colorectal resection. The cause of this is not fully understood, but rises in intraocular pressure (IOP) has been suggested as a possible factor. This may be particularly relevant in patients who have pre-existing high baseline IOP as a result of glaucoma. Studies looking at the effect of Trendelenburg positioning have shown that there is an increase in IOP. This study is to assess the effect of acetazolamide on the IOP rise after being placed in the Trendelenburg position. Acetazolamide is a carbonic anhydrase inhibitor which is used to treat glaucoma. The drug works by decreasing aqueous humour formation. It can be given as eye drops (but the absorption of this is variable and therefore so is the effect), orally and intravenously. The oral dose can be given as a one off dose or a divided dose. Maximum onset of IOP reduction occurs 2 to 5 hours after taking an oral dose and duration is 6-8 hours.

Aims:

This study aims to investigate the effect of acetazolamide on the IOP rise whilst in the Trendelenburg position.

Experimental protocol and methods:

This will be a pilot randomised crossover study with 9 healthy volunteers recruited and randomised to either Group 1 or Group 2. Group 1 will start with the Control Day; Group 2 will start with the Intervention Day. On the Control Day, a baseline IOP using a Tonopen XL will be taken. They will then be placed in 17 degrees head-down position 2.5hours after a placebo is administered for a minimum of 1 hour and a maximum of 4 hours. Repeat IOP measure will be taken whilst in the Trendelenburg position after 5 minutes, and then every 30 minutes from the start of Trendelenburg position. On the Intervention Day, baseline IOP will be taken, they will then be 500mgs of acetazolamide. After 2.5 hours, the volunteers will then be placed in the Trendelenburg position at 17 degrees for position for a minimum of 1hour and a maximum of 4 hours. Repeat IOP measure will be taken whilst in the Trendelenburg position after 5 minutes, and then every 30 minutes from the start of Trendelenburg position.

Inclusion criteria:

Healthy volunteers, aged 18 and over

Exclusions criteria

Pregnancy Breast Feeding Hepatic impairment Patients with pre-existing conditions affecting IOP regulation eg Glaucoma, previous eye surgery Regular medication affecting IOP Under the age of 18 Refusal to give written informed consent

Measurable endpoints/ statistical power

Primary endpoint: Comparison of IOP pressure before and after being placed in the Trendelenburg position between the two days - Day 1 volunteers will be administered with a placebo before being placed in the Trendelenburg position and Day 2 after acetazolamide has been administered.

Power: Bucci et al compared the effect of oral acetazolamide on IOP on 22 patients. They detected a 3.7mmHg decrease in IOP after 2 hours. Using this study, we powered our study to require 18 patients.

Conditions

IOP

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo and Trendelenburg Position

Volunteers received placebo medication and placed in Trendelenburg.

IOP will be measured. Participants will then be administered with a placebo and after 2.5 hours will be placed in 17 degrees head-down position for a minimum of 1 hour and maximum 4 hours. Repeat IOP measure will be taken whilst still in the Trendelenburg position after 5 mins and then every 30 minutes.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo was a sugar based placebo placed in a capsule.

Trendelenburg Position

Intervention Type: OTHER

Placed in Trendelenburg Position

Acetazolamide and Trendelenburg Position

Volunteer given acetazolomide and placed in Trendelenburg position and IOP measured.

IOP will be measured. Participants will then be administered with acetazolamide and after 2.5 hours placed in 17 degrees head-down position for a minimum of 1 hour and maximum 4 hours. Repeat IOP measure will be taken whilst still in the Trendelenburg position after 5 mins and then every 30 minutes.

Group Type: EXPERIMENTAL

Acetazolamide

Intervention Type: DRUG

Acetazolamide tablets were placed in capsules to make them look similar to placebo.

Trendelenburg Position

Intervention Type: OTHER

Placed in Trendelenburg Position

Interventions

Acetazolamide

Acetazolamide tablets were placed in capsules to make them look similar to placebo.

Intervention Type: DRUG

Placebo

Placebo was a sugar based placebo placed in a capsule.

Intervention Type: DRUG

Trendelenburg Position

Placed in Trendelenburg Position

Intervention Type: OTHER

Other Intervention Names

Diamox; Placebo arm, Placebo and Trendelenburg.

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers aged 18 and over

Exclusion Criteria

• Pregnancy
• Breast Feeding
• Hepatic impairment
• Patients with pre-existing conditions affecting IOP regulation eg Glaucoma, previous eye surgery
• Regular medication affecting IOP
• Under the age of 18
• Refusal to give written informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Parveen Vitish-Sharma, MRCS MSc

Role: PRINCIPAL_INVESTIGATOR

NDDC BRU

Other Identifiers

C12022015 SoM NDDC TaPPs

Identifier Type: -

Identifier Source: org_study_id