Trial Outcomes & Findings for Comparison of Intubation and Laryngeal Mask for Pars Plana Vitrectomy (NCT NCT02778932)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

148 participants

Primary outcome timeframe

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 posted on

2021-06-16

Participant Flow

Participant milestones

Participant milestones
Measure	Intubation Patients receiving general anesthesia including intubation and muscle Relaxation for pars plana-vitrectomy	Laryngeal Mask General anesthesia including laryngeal mask without muscle relaxation
Overall Study STARTED	74	74
Overall Study COMPLETED	74	74
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Intubation and Laryngeal Mask for Pars Plana Vitrectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ITN and Relaxation n=74 Participants General anesthesia including intubation and muscle relaxation	LM Without Relaxation n=74 Participants General anesthesia including laryngeal mask without muscle relaxation	Total n=148 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	43 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical >=65 years	35 Participants n=5 Participants	31 Participants n=7 Participants	66 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 12 • n=5 Participants	64 years STANDARD_DEVIATION 15 • n=7 Participants	64 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	37 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	37 Participants n=7 Participants	80 Participants n=5 Participants
Region of Enrollment Germany	74 Participants n=5 Participants	74 Participants n=7 Participants	148 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Population: Patients scheduled for pars plana vitrectomy

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.

Outcome measures

Outcome measures
Measure	ITN Without Relaxation n=74 Participants General anesthesia including intubation and muscle relaxation	LM Without Relaxation n=74 Participants General anesthesia including laryngeal mask without muscle relaxation
Number of Patients Moving During Pars Plana Vitrectomy (Count of Participants)	0 participants	9 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	ITN Without Relaxation n=74 Participants General anesthesia including intubation and muscle relaxation	LM Without Relaxation n=74 Participants General anesthesia including laryngeal mask without muscle relaxation
Quality of Immobilization	10 score on a scale Interval 8.0 to 10.0	10 score on a scale Interval 8.0 to 10.0

Adverse Events

LM Without Relaxation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ITN With Relaxation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Priv.-Doz. Dr. med. Axel Fudickar

University Hospital Schleswig-Holstein, Campus Kiel

Phone: 0049500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place