The Effect of Retrobulbar Block for Eye Surgery on Brain Oxygenation and Cognitive Functions in Elderly Patients

NCT03189329 | Completed Phase 4

• 1 other identifier: PYO.TIP.1904.15.009
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators measured changes in cerebral oxygen saturation (rSO2) and MMSE scores after retrobulbar block performed with levobupivacaine and lidocaine in patients undergoing vitreoretinal surgery.A total of 66 patients over the age of 60 undergoing vitreoretinal surgery with a total duration of less than 1 hour were included in this prospective, double-blinded study. The patients were randomly divided into two groups: group L (5ml, 2% lidocaine) and group LB (5ml, 0.5% levobupivacaine). Bilateral rSO2 measurements were recorded before the retrobulbar block and at 1-5 minutes post-block, during the procedure, and at 10-40 minutes post-op. MMSE was performed preoperatively and postoperatively in order to evaluate short term cognitive function. Sensory and motor block durations, pain, akinesia and conjunctival feeling scores, patient-surgeon satisfaction, and complications were also recorded.

Conditions

Vitreoretinal Surgery; Cognitive Function Abnormal; Intraoperative Monitoring

Keywords

NIR spectroscopy, cognitive function, eye, nerve block

Outcome Measures

Primary Outcomes (1)

• Cerebral oxygen saturation changes (rSO2)

  The NIRS device probes (INVOS-3100AR; Somanetics Inc., Troy, MI, USA) were placed at least 2 cm above the eyebrows and 3 cm away from the mid-line of the forehead, on right and left, in accordance with the instructions of manufacturer.The patient's forehead was cleaned with acetone alcohol before the sensor pads were glued, and wrapped with a bandage so that the sensors were not affected by ambient light. The patients were transferred to the operating table for measurement of bilateral rSO2, and preoxygenation was performed for three minutes using 4 L/min 100% oxygen via nasal cannula.

  The rSO2 value changes were recorded from baseline up to 40 minutes after surgery

Secondary Outcomes (11)

• Cognitive function measurement

  Cognitive functions were assessed from baseline up to 7 days after the surgery

• Sensory block onset time by the conjunctival feeling score using the cotton contact test.

  The sensory block onset time was recorded at the beginning of surgery till the first 15 min

• Sensory block end time by the conjunctival feeling score using the cotton contact test.

  The sensory block end time was recorded at the end of surgery till the first 24 h

• Motor block onset time by eye movements score.

  The motor block onset time was recorded at the beginning of surgery till the first 15 min

• Motor block end time by eye movements score.

  The motor block end time was recorded at the end of surgery till the first 24 h

Study Arms (2)

Group L

ACTIVE COMPARATOR

Patients undergoing block with 2% lidocaine hydrochloride

Drug: 2% lidocaine hydrochloride

Group LB

ACTIVE COMPARATOR

Patients undergoing block with 0.5% levobupivacaine

Drug: 0.5% levobupivacaine

Interventions

2% lidocaine hydrochloride DRUG

Retrobulbar block was performed with 5 ml of 2% lidocaine hydrochloride (AritmalR, Osel, Istanbul, Turkey) in Group L patients. The block was performed by the same practitioner (fourth year assistant of Ophthalmology Department) using inferotemporal approach as described by Sanderson using 27 gage disposable needles (Atkinson Retrobulbar NeedleR, Asico, USA)

Group L

0.5% levobupivacaine DRUG

and 5ml of 0.5% levobupivacaine (ChirocaineR, Abbvie, Chicago, USA) in Group LB patients. The block was performed by the same practitioner (fourth year assistant of Ophthalmology Department) using inferotemporal approach as described by Sanderson using 27 gage disposable needles (Atkinson Retrobulbar NeedleR, Asico, USA)

Group LB

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing vitreoretinal surgery (total duration \< 60 minutes)
• The ASA (American Society of Anesthesiologists) Classification I-III
• Over the age of 60
• The patiens who had no cognitive dysfunction

You may not qualify if:

• Contraindication for retrobulbar block
• Preoperative systolic blood pressure of 180 mmHg, diastolic blood pressure of above 100 mmHg
• Uncontrolled diabetes
• Body mass index ≥ 30 kg/m2
• MMSE ≤ 24
• Advanced organ failure
• Hb \< 9gr/dl

Sponsors & Collaborators

• Cengiz KAYA: lead
• Ondokuz Mayıs University: collaborator

Study Sites (1)

Ondokuz Mayis Universitesi

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (21)

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MeSH Terms

Conditions

Cognition Disorders

Interventions

Lidocaine; Levobupivacaine

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bupivacaine

Study Officials

• Cengiz Kaya, MD

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: June 10, 2017
• First Posted: June 16, 2017
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)