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

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ClinicalTrials.gov Identifier: NCT03107429
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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'.


Condition or disease Intervention/treatment Phase
IOP Drug: Acetazolamide Drug: Placebo Other: Trendelenburg Position Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: A pilot blinded randomised cross-over study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: A Pilot Crossover Study in Healthy Volunteers to Assess the Effect of Acetazolamide on Intraocular Pressure After Being in the Trendelenburg Position.
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : October 1, 2015
Actual Study Completion Date : October 1, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

Drug: Placebo
Placebo was a sugar based placebo placed in a capsule.
Other Name: Placebo arm, Placebo and Trendelenburg.

Other: Trendelenburg Position
Placed in Trendelenburg Position

Experimental: 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.

Drug: Acetazolamide
Acetazolamide tablets were placed in capsules to make them look similar to placebo.
Other Name: Diamox

Other: Trendelenburg Position
Placed in Trendelenburg Position




Primary Outcome Measures :
  1. Comparison of IOP pressure during Trendelenburg position after placebo and acetazolamide at each given time point outlined in methods. [ Time Frame: 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. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107429


Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Parveen Vitish-Sharma, MRCS MSc NDDC BRU

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03107429     History of Changes
Other Study ID Numbers: C12022015 SoM NDDC TaPPs
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Nottingham:
Trendelenburg
Laparoscopic colorectal surgery
POVL
Additional relevant MeSH terms:
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Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs