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

June 14, 2017 updated by: Cengiz KAYA

The Effect of Retrobulbar Block on Bi-Hemispheric Cerebral Oxygen Saturation and Early Period Postoperative Cognitive Functions With Lidocaine and Levobupivacaine in Elderly Patients With Ophthalmic Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 66 patients undergoing vitreoretinal surgery (total duration < 60 minutes) using retrobulbar block, who were classified as category I-III according to the ASA (American Society of Anesthesiologists) Classification system, who were over the age of 60, and who had no cognitive dysfunction were included in the study. Exclusion criteria were as follows: 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, or Hb < 9gr/dl.The patients were randomly divided into two groups using a sealed-envelope method:

Group L: Patients undergoing block with lidocaine (n = 33) Group LB: Patients undergoing block with levobupivacaine (n = 33) The patients did not undergo premedication in order to accommodate the postoperative MMSE evaluation. For intra-operative sedation, remifentanil (UltivaR, GlaxoSmithKline, Berntford, UK) was initiated as an infusion at a dose range of 0.05-0.1 mcg/kg/min. The mean arterial pressure and heart rate values were allowed to vary up to 20% of the preoperative values of the patients. For this purpose, the remifentanil infusion rate was increased or decreased at the determined dose interval.

Retrobulbar block was performed with 5 ml of 2% lidocaine hydrochloride (AritmalR, Osel, Istanbul, Turkey) in Group L patients 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).

Sensory and motor block onset and end times and akinesia score were recorded. The mean arterial pressure (MAP), heart rate (HR), and oxygen saturation (SpO2) were recorded in the preoperative period, at minutes 1, 3, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 intra-operatively, and at 10, 20, 30, and 40 minutes postoperatively in the recovery room.

. 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 basal oxygenation values were determined by taking the average of the last 30 s measurements. The rSO2 values were recorded at 1, 3, 5, 10, 15, 20, 25, 30th, 35, 40, 45, 50, 55, and 60 minutes after retrobulbar block, and at 10, 20, 30, and 40 minutes after the completion of the procedure.

Cognitive functions were assessed by the same technician using MMSE in the preoperative period, 40 minutes postoperatively and at 7 days after the operation (short term).Surgeon satisfaction was queried at the end of the case and patient satisfaction was questioned at the end of day.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 4

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

  • Turkey
    • Atakum
      • Samsun, Atakum, Turkey, 55139
        • Ondokuz Mayis Universitesi

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

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group L
Patients undergoing block with 2% lidocaine hydrochloride
Drug: 2% lidocaine hydrochloride
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)
ACTIVE_COMPARATOR: Group LB
Patients undergoing block with 0.5% levobupivacaine
Drug: 0.5% levobupivacaine
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral oxygen saturation changes (rSO2)
Time Frame: The rSO2 value changes were recorded from baseline up to 40 minutes after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function measurement
Time Frame: Cognitive functions were assessed from baseline up to 7 days after the surgery
Cognitive functions were assessed by the same technician using the Mini Mental State Examination (MMSE) test.
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.
Time Frame: The sensory block onset time was recorded at the beginning of surgery till the first 15 min
The sensory block onset time was recorded as the moment when the patient did not feel a piece of cotton touching the cornea. This time was measured by the conjunctival feeling score using the cotton contact test (0: normal, 1: less sensitive, 2: complete sensory loss). Score of 2 on the scale was considered as onset time for sensory block.
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.
Time Frame: The sensory block end time was recorded at the end of surgery till the first 24 h
The time at which recovery of sensory block was recovered was measured by the conjunctival feeling score using the cotton contact test (0: normal, 1: less sensitive, 2: complete sensory loss). Score of 0 on the scale was considered as end time for sensory block.
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.
Time Frame: The motor block onset time was recorded at the beginning of surgery till the first 15 min
The motor block onset time was recorded as the time that the patient's eye movements score was four or less. Eye movements score was measured over three points in each of the four quadrants as follows: 3, full eye movement and 0, no movement.
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.
Time Frame: The motor block end time was recorded at the end of surgery till the first 24 h
The time at which recovery of motor block was recovered was measured by the eye movements score (three points in each of the four quadrants as follows: 3, full eye movement and 0, no movement). Score of 12 on the scale was considered as end time for motor block.
The motor block end time was recorded at the end of surgery till the first 24 h
The akinesia score measurement
Time Frame: The akinesia score was assessed at the beginning of surgery till the first 15 min.
The akinesia score was assessed between 0-12 points after 10 minutes of block application. Eye movements were measured over three points in each of the four quadrants as follows: 3, full eye movement and 0, no movement. The sum of the movement scores across all four quadrants was recorded as the akinesian score. An eye with full movement was scored as 12, and an immobile eye was scored as 0. If the akinesia score was four or less, the block was considered successful.
The akinesia score was assessed at the beginning of surgery till the first 15 min.
The mean arterial pressure (MAP) measurement
Time Frame: The mean arterial pressure was recorded from baseline up to 40 minutes after surgery
The mean arterial pressure (MAP) was recorded in the preoperative period, at minutes 1, 3, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 intra-operatively, and at 10, 20, 30, and 40 minutes postoperatively in the recovery room.
The mean arterial pressure was recorded from baseline up to 40 minutes after surgery
The heart rate (HR) measurement
Time Frame: The heart rate (HR) was recorded from baseline up to 40 minutes after surgery
The heart rate (HR) was recorded in the preoperative period, at minutes 1, 3, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 intra-operatively, and at 10, 20, 30, and 40 minutes postoperatively in the recovery room.
The heart rate (HR) was recorded from baseline up to 40 minutes after surgery
The oxygen saturation (SpO2) measurement
Time Frame: The oxygen saturation (SpO2) was recorded from baseline up to 40 minutes after surgery
The oxygen saturation (SpO2) was recorded in the preoperative period, at minutes 1, 3, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 intra-operatively, and at 10, 20, 30, and 40 minutes postoperatively in the recovery room.
The oxygen saturation (SpO2) was recorded from baseline up to 40 minutes after surgery
Surgeon satisfaction
Time Frame: Surgeon satisfaction was queried at the end of the surgery till the first 15 min.
They were asked to score over 10 point scale. Surgeon satisfaction was evaluated using 10 point scale ( 0 = not satisfied at all and 10 = very satisfied)
Surgeon satisfaction was queried at the end of the surgery till the first 15 min.
Patient satisfaction
Time Frame: Patient satisfaction was questioned 24 hours after surgery
They were asked to score over 10 point scale. Patient satisfaction was evaluated using 10 point scale ( 0 = not satisfied at all and 10 = very satisfied)
Patient satisfaction was questioned 24 hours after surgery

Collaborators and Investigators

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

Sponsor

Cengiz KAYA

Collaborators

Ondokuz Mayıs University

Investigators

  • Principal Investigator: Cengiz Kaya, MD, Ondokuz Mayıs University

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.

General Publications

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 (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

June 10, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (ACTUAL)

June 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PYO.TIP.1904.15.009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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