Muscle RelaxationITNLMAPPVNCT02778932
Comparison of Intubation and Laryngeal Mask for Pars Plana Vitrectomy
An observational study of Muscle Relaxation, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Relaxation
- How many people
- 148 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Nov 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing pars plana vitrectomy under general anesthesia
Who may be able to join
- Patients undergoing pars plana vitrectomy under general anesthesia
Who cannot join
- Age below 18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Relaxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intubation | General anesthesia including intubation and muscle relaxation | |
| Laryngeal Mask | General anesthesia including laryngeal mask without muscle relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Moving During Pars Plana Vitrectomy (Count of Participants)
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.
Measured: 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 outcomes (1)
Quality of Immobilization
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)
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscle RelaxationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Fudickar, University Hospital Schleswig-Holstein
- Investigators
- Axel Fudickar, MD, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778932
- Sponsor's protocol ID
- D 466/16
- Acronym
- ITNLMAPPV
- Status last verified
- May 2021
- First submitted
- 8 May 2016
- Last updated
- 16 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Daien V, Turpin C, Lignereux F, Belghobsi R, Le Meur G, Lebranchu P, Pechereau A. Determinants of ocular deviation in esotropic subjects under general anesthesia. J Pediatr Ophthalmol Strabismus. 2013 May-Jun;50(3):155-60. doi: 10.3928/01913913-20130226-01. Epub 2013 Mar 5.
PubMed 23451722Rossiter JD, Wood M, Lockwood A, Lewis K. Operating conditions for ocular surgery under general anaesthesia: an eccentric problem. Eye (Lond). 2006 Jan;20(1):55-8. doi: 10.1038/sj.eye.6701789.
PubMed 15650757Spiteri N, Sidaras G, Czanner G, Batterbury M, Kaye SB. Assessing the quality of ophthalmic anesthesia. J Clin Anesth. 2015 Jun;27(4):285-9. doi: 10.1016/j.jclinane.2015.01.008. Epub 2015 Feb 18.
PubMed 25704674
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immobilization Quality During General Anesthesia for Pars Plana-vitrectomy With and Without Neuromuscular Blockade and Endotracheal Intubation Measured by a Questionnaire
- ClinicalTrials.gov ID
- NCT02778932
- Acronym / sponsor ID
- ITNLMAPPV / D 466/16
- Conditions
- Muscle Relaxation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Posted 16 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubation | – | –General anesthesia including intubation and muscle relaxation |
| Laryngeal Mask | – | –General anesthesia including laryngeal mask without muscle relaxation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing pars plana vitrectomy under general anesthesia
Key inclusion criteria (1 listed)
- Patients undergoing pars plana vitrectomy under general anesthesia
Key exclusion criteria (1 listed)
- Age below 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23451722Daien V, Turpin C, Lignereux F, Belghobsi R, Le Meur G, Lebranchu P, Pechereau A. Determinants of ocular deviation in esotropic subjects under general anesthesia. J Pediatr Ophthalmol Strabismus. 2013 May-Jun;50(3):155-60. doi: 10.3928/01913913-20130226-01. Epub 2013 Mar 5.
- Background: PubMed 15650757Rossiter JD, Wood M, Lockwood A, Lewis K. Operating conditions for ocular surgery under general anaesthesia: an eccentric problem. Eye (Lond). 2006 Jan;20(1):55-8. doi: 10.1038/sj.eye.6701789.
- Background: PubMed 25704674Spiteri N, Sidaras G, Czanner G, Batterbury M, Kaye SB. Assessing the quality of ophthalmic anesthesia. J Clin Anesth. 2015 Jun;27(4):285-9. doi: 10.1016/j.jclinane.2015.01.008. Epub 2015 Feb 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Fudickar, MD principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Relaxation, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02778932, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.