Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia

NCT07347886 | Not Yet Recruiting

• 1 other identifier: 1503993
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Topical anesthesia, sedation, patient satisfaction, ISAS-T

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Intraoperative sedation level

  During surgery (intraoperative period

• Preoperative anxiety level

  Preoperative period (before surgery)

• Surgeon satisfaction

  Immediately after surgery

• İntraoperative heart rate

  During surgery

• İntraoperative mean arterial pressure

  During surgery

Study Arms (3)

Topical anesthesia only (placebo)

PLACEBO COMPARATOR

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

Topical anesthesia + midazolam

EXPERIMENTAL

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

Topical anesthesia + midazolam + fentanyl

EXPERIMENTAL

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; Drug: Fentanyl (IV)

Interventions

Normal Saline DRUG

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

Also known as: Pacebo

Topical anesthesia only (placebo)

Midalozam 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.

Also known as: Dormicum

Topical anesthesia + midazolam; Topical anesthesia + midazolam + fentanyl

Fentanyl (IV) 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.

Also known as: Fentanyl citrtate

Topical anesthesia + midazolam + fentanyl

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 9357889 BACKGROUND

MeSH Terms

Conditions

Cataract; Patient Satisfaction

Interventions

Saline Solution; PACEBO protocol; Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gürcan Güngör, MD, Associate professor

  İstanbul University-Cerrahpaşa

  PRINCIPAL INVESTIGATOR

• Cezmi Doğan, MD, Associate professor

  İstanbul University-Cerrahpaşa

  STUDY CHAIR

Central Study Contacts

Bekzat Emilbekov, Anesthesiology resident

CONTACT

+90 544 586 14 33; bekzatemilbekov@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and the operating surgeon will be blinded to group allocation. Study medications, including placebo saline in the non-sedation group, will be prepared in identical syringes by an independent clinician not involved in patient care or outcome assessment. Sedative agents will be administered in equal volumes to maintain blinding. Postoperative outcomes, including patient satisfaction, will be evaluated by a blinded outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant in Anesthesiology

Model Details: Participants will be randomly assigned to one of three parallel groups, each receiving a different sedation strategy during cataract surgery under topical anesthesia.

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)