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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03189329
• Date of registration: 10/06/2017
• Prospective Registration: No
• Primary sponsor: Cengiz KAYA
• Public title: The Effect of Retrobulbar Block for Eye Surgery on Brain Oxygenation and Cognitive Functions in Elderly Patients
• Scientific title: 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
• Date of first enrolment: January 2015
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03189329
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Investigator).
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Cengiz Kaya, MD
• Affiliation: Ondokuz Mayis University

Key inclusion & exclusion criteria

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



Age minimum: 60 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cognitive Function Abnormal

Vitreoretinal Surgery

Intraoperative Monitoring

Intervention(s)

Drug: 2% lidocaine hydrochloride

Drug: 0.5% levobupivacaine

Primary Outcome(s)

Cerebral oxygen saturation changes (rSO2) [Time Frame: The rSO2 value changes were recorded from baseline up to 40 minutes after surgery]

Secondary Outcome(s)

The akinesia score measurement [Time Frame: The akinesia score was assessed at the beginning of surgery till the first 15 min.]

The oxygen saturation (SpO2) measurement [Time Frame: The oxygen saturation (SpO2) was recorded from baseline up to 40 minutes after surgery]

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 heart rate (HR) measurement [Time Frame: The heart rate (HR) was recorded from baseline up to 40 minutes after surgery]

The mean arterial pressure (MAP) measurement [Time Frame: The mean arterial pressure was recorded from baseline up to 40 minutes after surgery]

Patient satisfaction [Time Frame: Patient satisfaction was questioned 24 hours after surgery]

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]

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]

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]

Cognitive function measurement [Time Frame: Cognitive functions were assessed from baseline up to 7 days after the surgery]

Surgeon satisfaction [Time Frame: Surgeon satisfaction was queried at the end of the surgery till the first 15 min.]

Secondary ID(s)

PYO.TIP.1904.15.009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ondokuz Mayis University