Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia (SADCAT)

This study aims to evaluate the clinical outcomes of different sedation strategies in patients undergoing cataract surgery performed under topical anesthesia. Cataract surgery is commonly performed under topical anesthesia; however, some patients may experience anxiety, discomfort, or inadequate cooperation during the procedure. Sedation may improve patient comfort and surgical conditions, but it may also be associated with potential adverse effects.

In this randomized, prospective study, patients will be assigned to one of three groups: topical anesthesia alone, topical anesthesia combined with midazolam, or topical anesthesia combined with midazolam and fentanyl. Intraoperative sedation levels, hemodynamic parameters, patient satisfaction, and surgeon satisfaction will be assessed and compared among the groups.

The results of this study are expected to provide evidence regarding the effectiveness and safety of sedation during cataract surgery performed under topical anesthesia and to help optimize perioperative sedation strategies for these patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Drug: Normal Saline; Drug: Midalozam; Drug: Fentanyl (IV)

Detailed Description

Cataract surgery is one of the most frequently performed ophthalmologic procedures and is commonly carried out under topical anesthesia. Although topical anesthesia provides adequate analgesia, some patients may experience anxiety, discomfort, or difficulty in maintaining cooperation during the procedure. Sedation is frequently used as an adjunct to topical anesthesia to improve patient comfort and surgical conditions; however, concerns remain regarding potential respiratory and hemodynamic adverse effects, particularly in elderly patients.

This prospective, randomized clinical study is designed to evaluate the clinical outcomes of different sedation strategies in patients undergoing cataract surgery performed under topical anesthesia. Adult patients scheduled for elective cataract surgery will be randomly assigned to one of three groups. Group 1 will receive topical anesthesia alone without sedation. Group 2 will receive topical anesthesia combined with intravenous midazolam. Group 3 will receive topical anesthesia combined with intravenous midazolam and fentanyl. Randomization will be performed using a predefined allocation method to ensure balanced group distribution.

All patients will be monitored using standard intraoperative monitoring, including non-invasive blood pressure, electrocardiography, and peripheral oxygen saturation. Supplemental oxygen will be administered when clinically indicated. Sedative agents will be administered according to standardized dosing protocols. Intraoperative sedation depth will be assessed using a validated sedation scale, and hemodynamic and respiratory parameters will be recorded throughout the procedure.

The primary outcome of the study is postoperative patient satisfaction, which will be assessed using the Iowa Satisfaction with Anesthesia Scale - Turkish version (ISAS-T). Secondary outcomes include intraoperative sedation level, surgeon satisfaction, hemodynamic stability, respiratory events, additional sedative requirements, and the occurrence of sedation-related adverse effects. Surgeon satisfaction will be evaluated using a standardized Likert-type scale.

The results of this study are expected to provide evidence regarding the impact of different sedation strategies on patient satisfaction and overall clinical outcomes in cataract surgery performed under topical anesthesia. These findings may contribute to optimizing perioperative sedation practices and improving patient-centered care in ophthalmic anesthesia.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bekzat Emilbekov, Anesthesiology resident; Phone Number: +90 544 586 14 33; Email: bekzatemilbekov@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
    • Contact: Bekzat Emilbekov, Anesthesiology resident; Phone Number: +90 544 586 14 33; Email: bekzatemilbekov@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 50 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Patients scheduled for elective unilateral cataract surgery
• Surgery planned to be performed under topical anesthesia
• Ability to understand the study procedures and provide written informed consent after being fully informed about the study

Exclusion Criteria:

• Refusal to participate in the study or withdrawal of consent at any stage of the study
• Known intolerance or contraindication to sedative and/or opioid medications
• Presence of significant cardiac arrhythmias
• Severe chronic obstructive pulmonary disease (COPD)
• Hepatic or renal failure
• Inability to cooperate due to cognitive impairment or hearing disability
• Opioid dependence
• Diagnosis of obstructive sleep apnea syndrome (OSAS)
• New York Heart Association (NYHA) class III-IV heart failure
• Conversion to general anesthesia for any reason during surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Topical anesthesia only (placebo); Patients will receive topical anesthesia for cataract surgery. An intravenous placebo (normal saline) will be administered in an identical volume to maintain blinding. No sedative or opioid medication will be given.	Drug: Normal Saline; Intravenous normal saline administered in an identical volume as placebo to maintain blinding. No sedative or opioid medication will be given.; Other Names: Pacebo
Experimental: Topical anesthesia + midazolam; Patients will receive topical anesthesia combined with intravenous midazolam administered for sedation during cataract surgery. The medication will be prepared and administered in a standardized dose and volume to maintain blinding.	Drug: Midalozam; Intravenous midazolam administered for procedural sedation during cataract surgery performed under topical anesthesia. The medication will be prepared and administered in standardized doses and identical volumes to maintain blinding.; Other Names: Dormicum
Experimental: Topical anesthesia + midazolam + fentanyl; Patients will receive topical anesthesia combined with intravenous midazolam and fentanyl for sedation during cataract surgery. Medications will be administered in standardized doses and equal volumes to ensure blinding across study groups.	Drug: Midalozam; Intravenous midazolam administered for procedural sedation during cataract surgery performed under topical anesthesia. The medication will be prepared and administered in standardized doses and identical volumes to maintain blinding.; Other Names: Dormicum; Drug: Fentanyl (IV); intravenous fentanyl administered in combination with midazolam to provide analgesia and sedation during cataract surgery under topical anesthesia. The medication will be prepared and administered in standardized doses and equal volumes to ensure blinding across study groups.; Other Names: Fentanyl citrtate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction after cataract surgery	Patient satisfaction will be assessed using the validated Turkish version of the Iowa Satisfaction with Anesthesia Scale (ISAS-T). The ISAS-T total score will be calculated according to the instrument instructions; higher scores indicate greater satisfaction.	1 hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative sedation level	Intraoperative sedation depth will be assessed using the Ramsay Sedation Scale during cataract surgery performed under topical anesthesia.	During surgery (intraoperative period
Preoperative anxiety level	Preoperative anxiety will be assessed using the Turkish version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS).	Preoperative period (before surgery)
Surgeon satisfaction	Surgeon satisfaction will be assessed using a 5-point Likert scale.	Immediately after surgery
İntraoperative heart rate	Heart rate will be continuously monitored intraoperatively using standard anesthesia monitoring. Values will be recorded at predefined time points during surgery.	During surgery
İntraoperative mean arterial pressure	Mean arterial pressure will be measured intraoperatively using non-invasive blood pressure monitoring. Measurements will be recorded at predefined time points during surgery.	During surgery
Respiratory events	Intraoperative respiratory events will be assessed using continuous pulse oximetry (SpO₂ monitoring) and clinical airway intervention records. Oxygen desaturation will be defined as SpO₂ < 90% lasting ≥ 10 seconds. Airway support will be recorded as the need for any of the following interventions: jaw thrust, chin lift, insertion of an oral or nasal airway, or assisted ventilation via face mask. Each event will be recorded as a binary outcome (yes/no) during the intraoperative period.	During surgery

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Investigators: Principal Investigator: Gürcan Güngör, MD, Associate professor, Istanbul University-Cerrahpaşa; Study Chair: Cezmi Doğan, MD, Associate professor, Istanbul University-Cerrahpaşa

Publications and helpful links

General Publications

• Dexter F, Aker J, Wright WA. Development of a measure of patient satisfaction with monitored anesthesia care: the Iowa Satisfaction with Anesthesia Scale. Anesthesiology. 1997 Oct;87(4):865-73. doi: 10.1097/00000542-199710000-00021.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 27, 2025
• First Submitted That Met QC Criteria: January 11, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Topical anesthesia, sedation, patient satisfaction, ISAS-T
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior; Cataract; Patient Satisfaction; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Piperidines; Crystalloid Solutions; Isotonic Solutions; Solutions; Benzazepines; Benzodiazepines; Midazolam; Fentanyl; Saline Solution; PACEBO protocol
• Other Study ID Numbers: 1503993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to the nature of this single-center academic thesis study and to protect participant confidentiality. No formal data-sharing agreement has been planned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No