Comparison of Intubation and Laryngeal Mask for Pars Plana Vitrectomy (ITNLMAPPV)

May 21, 2021 updated by: Axel Fudickar, University Hospital Schleswig-Holstein

Comparison of Immobilization Quality During General Anesthesia for Pars Plana-vitrectomy With and Without Neuromuscular Blockade and Endotracheal Intubation Measured by a Questionnaire

Pars plana vitrectomy is usually performed under general anesthesia including endotracheal intubation and muscle relaxation. However, for short procedures anesthesia using a laryngeal mask without muscle relaxation is also common in practice. In this observational study the incidence of patient movement will be examined between these anesthesia techniques.

Study Overview

Status

Completed

Conditions

Detailed Description

Usually eye surgery can be safely performed under local anesthesia. However, if the eye is opened during the procedure, general anesthesia may be a safer alternative. The intraocular pressure is less stable in wake patients than in anesthetized patients and increasing intraocular pressure can lead to prolapse of vitreous. Moreover, wake patients may move during the procedure and movement during surgery can cause serious lesions of the retina with consecutive loss of vision due to intraocular instruments.

A typical intraocular procedure is vitrectomy. During vitrectomy the vitreous body is removed and substituted by silicon oil or gas. Vitrectomy is usually performed by inserting instruments through the pars plana in the eye. The pars plana, an area between iris and retina, contains no structures essential for vision. On one side of the eye a light source and access for intraocular infusion is introduced into the eye through the pars plana. An infusion is connected and fixed at 60 cm above eye level thus maintaining intraocular pressure by gravity. On the opposite side of the eye instruments like scalpels, scissors or an instrument combining cutting and suction of vitreous can be inserted through a tube. Common indications for vitrectomy are vitreous body bleedings or retinal detachment.

Reliable immobilization by anesthesia is mandatory for vitrectomy. However, anesthesia for vitrectomy is complicated by the fact that the anatomical structures at risk are reached very early during operation and consequently there is not much time to adopt anesthesia dosage to individual patient's needs. At the end of the procedure the critical area is left a few minutes before conjunctival suture leaving a relatively short period of time for recovery from anesthesia until extubation.

Possibly due to these difficulties deviation of vision axis and patient movements are not uncommon during general anesthesia for eye operations. Usually these events can be dealt with by supplementation of anesthesia and muscle relaxation, but they can lead to impairment of operation conditions and put the patient at risk of eye damage and loss of vision. Rossiter and co-workers investigated quality of immobilisation in 52 patients during eye surgery. Even small eye movements like upward deviation of the vision axis have been regarded as incomplete immobilisation in this study because they interfere with surgery and thereby increase the risk of complications.

In four of these 52 patients (7.6 %) eye movements have been observed during surgery (Rossiter 2006). It has been shown by a further study that these deviations can be quantified and depend from the patient's preoperative findings (Daien 2013).

Vitrectomy is performed as 20-gauge- or 23-gauge sutureless transconjunctival vitrectomy, depending of the diameter of the intraocular access channel (Aylward 2011)3. Generally, operation time is considerably shorter for 23-Gauge-vitrectomie, because no conjunctival suture is needed. Hence, 23 Gauge-vitrectomies are performed under general anesthesia using a laryngeal mask without muscle relaxation at our institution. 20-Gauge-vitrectomies are performed under general anesthesia with endotracheal intubation due to longer operation times. However, total muscle relaxation is maintained only during the first 30 - 45 min of surgery until reliable immobilization is reached by volatile anesthetics. The results of Rossiter and co-workers showed that eye movements occurred only during surgery without muscle relaxation in their study. Hence, it may be argued that immobilization by balanced anesthesia only during 23 Gauge-vitrectomy and during the second half of 20 Gauge-vitrectomy may be inferior to immobilization by addition of muscle relaxants.

Objective of this prospective observational study is the comparison of immobilization quality during general anesthesia for pars plana-vitrectomy with and without neuromuscular blockade and endotracheal intubation.

Study Type

Observational

Enrollment (Actual)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • University Hospital Schleswig-Holstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing pars plana vitrectomy under general anesthesia

Description

Inclusion Criteria:

  • Patients undergoing pars plana vitrectomy under general anesthesia

Exclusion Criteria:

  • Age below 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intubation
General anesthesia including intubation and muscle relaxation
Laryngeal Mask
General anesthesia including laryngeal mask without muscle relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Moving During Pars Plana Vitrectomy (Count of Participants)
Time Frame: The estimated period of time over which the event is assessed is the time between incision and suture (estimated period of time: 30 - 180 min).
Movements of patients and abnormal deviations of eye position during surgery were reported to the anesthetist by the surgeon and noted by the anesthetist. Each patient with movement or abnormal deviations of eye position was counted as patient moving during pars plana vitrectomy (Count of participants). No score was used to report movement. Hence, no further score informations can be included.
The estimated period of time over which the event is assessed is the time between incision and suture (estimated period of time: 30 - 180 min).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Immobilization
Time Frame: The estimated period of time over which the event is assessed is the time between incision and suture (estimated period of time: 30 - 180 min).
Quality of immobilization will be investigated by interviewing surgeons using a standardized questionnaire including quality of eye position, general immobilization, akinesia of the eye, blood loss, intraocular pressure, surgeon satisfaction with immobilization and anesthesia. Outcome measure is the surgeon's satisfaction measured on a score between 0 and 10 (Score title: Questionnaire for quantification of immobilization during general anesthesia for pars-plana vitrectomy. Higher scores mean a better outcome. 0 = None (Minimum), worst outcome, 10 = Maximal (Maximum), best outcome, Title: Quality of immobilization)
The estimated period of time over which the event is assessed is the time between incision and suture (estimated period of time: 30 - 180 min).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Axel Fudickar, MD, University Hospital Schleswig-Holstein, Campus Kiel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 8, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • D 466/16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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