Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia

NCT ID: NCT07347886

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-10-31

Brief Summary

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.

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Intravenous normal saline administered in an identical volume as placebo to maintain blinding. No sedative or opioid medication will be given.

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.

Group Type: EXPERIMENTAL

Midalozam

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Midalozam

Intervention Type: DRUG

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.

Fentanyl (IV)

Intervention Type: DRUG

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.

Interventions

Normal Saline

Intravenous normal saline administered in an identical volume as placebo to maintain blinding. No sedative or opioid medication will be given.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Pacebo; Dormicum; Fentanyl citrtate

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Bekzat Emilbekov

Research Assistant in Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gürcan Güngör, MD, Associate professor

Role: PRINCIPAL_INVESTIGATOR

İstanbul University-Cerrahpaşa

Cezmi Doğan, MD, Associate professor

Role: STUDY_CHAIR

İstanbul University-Cerrahpaşa

Locations

Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Bekzat Emilbekov, Anesthesiology resident

Role: CONTACT

bekzatemilbekov@gmail.com

+90 544 586 14 33

Facility Contacts

Bekzat Emilbekov, Anesthesiology resident

Role: primary

bekzatemilbekov@gmail.com

+90 544 586 14 33

References

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.

Reference Type: BACKGROUND

PMID: 9357889 (View on PubMed)

Other Identifiers

1503993

Identifier Type: -

Identifier Source: org_study_id