CataractSADCATNCT07347886
Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia
A study testing Normal Saline, Midalozam and Fentanyl (IV) in people with Cataract, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Normal Saline, Midalozam and Fentanyl (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
Istanbul
Bekzat Emilbekov, Anesthesiology resident, +90 544 586 14 33, bekzatemilbekov@gmail.com
About this study
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.
Read the 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
- Being tested
- Normal Saline, Midalozam, Fentanyl (IV)
- Keywords
- Topical anesthesia, sedation, patient satisfaction, ISAS-T
- Medical subject headings
- Cataract, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Also called Pacebo
Intravenous normal saline administered in an identical volume as placebo to maintain blinding. No sedative or opioid medication will be given.
MidalozamDrug
Also called Dormicum
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)Drug
Also called Fentanyl citrtate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Midalozam; Drug: Fentanyl (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour postoperatively
Secondary outcomes (6)
Intraoperative sedation level
Intraoperative sedation depth will be assessed using the Ramsay Sedation Scale during cataract surgery performed under topical anesthesia.
Measured: 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).
Measured: Preoperative period (before surgery)
Surgeon satisfaction
Surgeon satisfaction will be assessed using a 5-point Likert scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel groups, each receiving a different sedation strategy during cataract surgery under topical anesthesia.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bekzat Emilbekov, Istanbul University - Cerrahpasa
- Investigators
- Gürcan Güngör, MD, Associate professor, Principal investigator, İstanbul University-CerrahpaşaCezmi Doğan, MD, Associate professor, Study chair, İstanbul University-Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347886
- Sponsor's protocol ID
- 1503993
- Acronym
- SADCAT
- Status last verified
- Jan 2026
- First submitted
- 27 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 9357889
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Sedation in Cataract Surgery Performed Under Topical Anesthesia
- ClinicalTrials.gov ID
- NCT07347886
- Acronym / sponsor ID
- SADCAT / 1503993
- Conditions
- Cataract
- Keywords
- Topical anesthesia, sedation, patient satisfaction, ISAS-T
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel groups, each receiving a different sedation strategy during cataract surgery under topical anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Topical anesthesia only (placebo) | Placebo comparator | Drug: Normal SalinePatients 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. |
| Topical anesthesia + midazolam | Experimental | Drug: MidalozamPatients 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. |
| Topical anesthesia + midazolam + fentanyl | Experimental | Drug: Midalozam, Drug: Fentanyl (IV)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal SalineAlso: PaceboIntravenous normal saline administered in an identical volume as placebo to maintain blinding. No sedative or opioid medication will be given. | Drug | Topical anesthesia only (placebo) |
| MidalozamAlso: DormicumIntravenous 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. | Drug | Topical anesthesia + midazolam, Topical anesthesia + midazolam + fentanyl |
| Fentanyl (IV)Also: Fentanyl citrtateintravenous 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. | Drug | Topical anesthesia + midazolam + fentanyl |
Primary outcome
Patient satisfaction after cataract surgery
Time frame: 1 hour postoperatively
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.
6 secondary outcomes
Intraoperative sedation level
Time frame: During surgery (intraoperative period
Preoperative anxiety level
Time frame: Preoperative period (before surgery)
Surgeon satisfaction
Time frame: Immediately after surgery
İntraoperative heart rate
Time frame: During surgery
İntraoperative mean arterial pressure
Time frame: During surgery
Respiratory events
Time frame: During surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 9357889Dexter 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gürcan Güngör, MD, Associate professor principal investigator
İstanbul University-Cerrahpaşa
Cezmi Doğan, MD, Associate professor study chair
İstanbul University-Cerrahpaşa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Saline, Midalozam and Fentanyl (IV) in people with Cataract, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bekzat Emilbekov, Anesthesiology resident (+90 544 586 14 33, bekzatemilbekov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction after cataract surgery (time frame: 1 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07347886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.