Effects of Nitrous Oxide on Intraocular Pressure

This study has been terminated.
(PI is no longer at this institution)
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00696189
First received: June 9, 2008
Last updated: March 12, 2010
Last verified: March 2010
  Purpose

The concept of ocular perfusion pressure (OPP), is defined as the difference between the mean arterial pressure (MAP) and the intraocular pressure (IOP.)It has been hypothesized that unopposed decreases in MAP, increases in IOP or a combination of the two may result in hypo perfusion of the eye and can cause an ocular infarction at the level of the retina or optic nerve, leading to varying degrees of visual loss which is frequently bilateral and irreversible.

Both the prone position and downward head tilting (Trendelenburg position) have been associated with increases in IOP compared to the supine horizontal position (2,4,5,6), but it is not known whether the Trendelenburg position during surgery and anesthesia is associated with POVL.


Condition
Post Operative Visual Loss

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Nitrous Oxide on Intraocular Pressure and Ocular Perfusion

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Enrollment: 30
Study Start Date: September 2006
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Our preliminary Phase I studies using awake volunteers confirmed the increase in IOP associated with the prone position which is attenuated, although not eliminated, with a 15 cm head up table elevation. In addition we found evidence of retinal vascular changes consistent with venous congestion over a one hour period in the prone position in five awake volunteers using digital retinal imaging.

It is known that general anesthesia decreases IOP. A critical element, however, which has not been definitively studied is the effect of individual anesthetics, specifically nitrous oxide, on IOP. It is known that nitrous oxide does increase IOP when inert gases are injected into the vitreous for treatment of retinal detachment and this phenomenon can last up to six weeks, resulting in permanent vision loss with its use. It has also been shown that nitrous oxide increases intracranial pressure (ICP,9) although this effect may be attenuated by narcotics and additional intravenous anesthetic agents. It also increases cerebral metabolic rate, potentially aggravating any compromise in blood flow. Several studies showed a significant association between elevated IOP and ICP. Therefore, it is critical to attempt to isolate the effect of nitrous oxide on IOP. Because nitrous oxide is used as an adjunct to other anesthetics, it is the most frequently used of all the inhalation anesthetics and delineating its effect on this variable will help clinicians decide whether the advantage of its use outweighs the risk.

Because general anesthesia decreases IOP and there is significant variation between subjects this study is planned using a within subject design. Patients undergoing open gynecological procedures such as hysterectomies and patients undergoing orthopedic surgery are ideal candidates for the proposed study for the following reasons. The majority of patients undergoing general anesthesia in University Hospital operating rooms require frequent table position changes which might affect the results. Therefore, we choose to study patients who will remain in one position for the majority of the operation. The hysterectomy patients offer a unique benefit because It would also be advantageous to study patients in a position known to increase IOP in order to better detect differences in anesthetic regimen and isolate the effects of a specific agent. In addition, patients undergoing orthopedic surgery such as hand and ankle procedures are commonly in a fixed supine position for the predominance of the operation. University Hospital conducts a considerably greater number of orthopedic cases than gynecological cases daily which allows for greater ease in patient enrollment. Measuring IOP in the supine Trendelenburg position offers significant technical and logistical advantages compared to the prone position and therefore taking our measurements in this position is desirable.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Ages of 18 and 65 years of age and mentally capable of giving consent. Scheduled for gynecological surgery and will be placed in the Trendelenburg position (head lower than my waist) on the operating room table.

Criteria

Inclusion Criteria:

  • If I am between the ages of 18 and 65 years of age and mentally capable of giving consent.
  • If I am scheduled for gynecological surgery and will be placed in the Trendelenburg position (head lower than my waist) on the operating room table.

Exclusion Criteria:

  • If I fail/refuse to provide an informed consent
  • If I have a history of stroke or trans-ischemic attack (TIA).
  • If I have a history of corneal disease.
  • If I a have a sensitivity to eye drops called proparacaine
  • If I have had a previous diagnosis of carotid disease.
  • If I have a history of glaucoma
  • If I am taking medications which may affect the pressure in my eyes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696189

Locations
United States, New Jersey
UMDNJ
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Geordie Grant, MD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Geordie Grant, MD, UMDNJ
ClinicalTrials.gov Identifier: NCT00696189     History of Changes
Other Study ID Numbers: 0120060249, 0120060249
Study First Received: June 9, 2008
Last Updated: March 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Post operative visual loss (POVL)
Intraocular pressure (IOP)
Nitrous oxide

Additional relevant MeSH terms:
Vision, Low
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Nitrous Oxide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 29, 2014