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

NCT03107429 | Completed

• 1 other identifier: C12022015 SoM NDDC TaPPs
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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'.

Conditions

IOP

Keywords

Trendelenburg; Laparoscopic colorectal surgery; POVL

Outcome Measures

Primary Outcomes (1)

• Comparison of IOP pressure during Trendelenburg position after placebo and acetazolamide at each given time point outlined in methods.

  IOP measurements will be taken at each described time point on both study days and the difference in IOP measurement after acetazolamide will be compared to those after placebo.

  6 days. 2 Days involved in study (6 hours each) and a minimum of 5 days between study days to allow 'wash-out period' of drug.

Study Arms (2)

Placebo and Trendelenburg Position

ACTIVE COMPARATOR

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.

Drug: Placebo; Other: Trendelenburg Position

Acetazolamide and Trendelenburg Position

EXPERIMENTAL

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.

Drug: Acetazolamide; Other: Trendelenburg Position

Interventions

Acetazolamide DRUG

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

Also known as: Diamox

Acetazolamide and Trendelenburg Position

Placebo DRUG

Placebo was a sugar based placebo placed in a capsule.

Also known as: Placebo arm, Placebo and Trendelenburg.

Placebo and Trendelenburg Position

Trendelenburg Position OTHER

Placed in Trendelenburg Position

Acetazolamide and Trendelenburg Position; Placebo and Trendelenburg Position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers aged 18 and over

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

MeSH Terms

Interventions

Acetazolamide; Head-Down Tilt

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Parveen Vitish-Sharma, MRCS MSc

  NDDC BRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo and Acetazolamide tablets were placed into capsules that were the same by the Pharmacy department. A separate investigator generated a randomisation list for 11 volunteers to decide if a placebo or acetazolamide will be taken on Day 1. They then created envelopes with the corresponding medication in Day 1 and the other in Day 2 and these were marked as Volunteer 1, 2, 3 etc. The randomisation list was sealed and kept with each investigator so they could be accessed if required due to any adverse events. The volunteers will be recruited and both the investigators and the volunteers were blinded to what was received on each study day.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pilot blinded randomised cross-over study.

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: April 11, 2017
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share