Cataract Surgery AnesthesiaPhase 4NCT07036367
The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery
A Phase 4 study testing Sublingual Melatonin in people with Cataract Surgery Anesthesia, run by Al-Azhar University at 2 sites in 2 countries.
Trial summary
Cataract surgery is routinely performed with anesthesia care, whereas anesthesia care for other elective, low-risk, outpatient procedures is applied more selectively. We hypothesize that sublingual melatonin will provide superior anxiolysis and sedation while maintaining a high safety profile and minimizing… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cataract Surgery Anesthesia
- What is being tested?
- Sublingual Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2025to 15 Jun 2026
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age ≥ 60 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for unilateral cataract surgery under local anesthesia
- Ability to understand and complete study-related questionnaires
Who cannot join
- • Known allergy or hypersensitivity to melatonin
- Chronic use of sedatives, hypnotics, or anxiolytics
- History of sleep disorders or psychiatric illness
- Visual or hearing impairment that would hinder communication
- Emergency surgery or anticipated intraoperative complications
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Egypt1 site, 1 recruiting
- Not yet recruiting
Al-Azhar University
Cairo, Egypt, 11865
Neveen Kohaf, PhD, 01060383012, nevenabdo@azhar.edu.eg
Haider Hamza, M.D, +9647811593388, hussein.hussein@alayen.edu.iq
Iraq1 site, 1 recruiting
- Recruiting
Al-Azhar University
Baghdad, Baghdad Governorate, 10011
Neveen, 01069482380, nevenabdo@azhar.edu.eg
About this study
Cataract surgery is routinely performed with anesthesia care, whereas anesthesia care for other elective, low-risk, outpatient procedures is applied more selectively. We hypothesize that sublingual melatonin will provide superior anxiolysis and sedation while maintaining a high safety profile and minimizing hemodynamic disturbances.
Read the detailed description
Prevalence of anesthesia care during cataract surgery compared with other low-risk procedures; association of anesthesia care with patient, clinician, and health system characteristics; and proportion of patients experiencing a significant anxiety and hemodynamic instability during cataract surgery.
- Conditions
- Cataract Surgery Anesthesia
- Being tested
- Sublingual Melatonin, Sublingual Placebo
- Keywords
- Melatonin, Geriatric, Cataract Surgery, Premedication, Sedation, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual MelatoninDrug
Participants in this group received 3 mg of sublingual melatonin, administered 60 minutes before cataract surgery. The melatonin was given in the form of a rapidly dissolving sublingual tablet to enhance bioavailability and ensure consistent preoperative absorption. The goal of the intervention was to reduce preoperative anxiety, improve sedation level, and stabilize hemodynamic parameters. The melatonin tablets were indistinguishable in appearance from the placebo and were prepared and dispensed by a pharmacy technician not involved in data collection or patient care
Sublingual PlaceboDrug
Participants in this group received an identical-appearing sublingual placebo tablet containing inert ingredients, administered 60 minutes before cataract surgery. The placebo was visually indistinguishable from the melatonin tablets and was used to maintain double blinding in the trial. Tablets were prepared by the pharmacy team to ensure concealment and eliminate bias. This group was designed to serve as a control to evaluate the effectiveness of sublingual melatonin on anxiety and sedation levels in elderly patients
| Study group | Role | What they receive |
|---|---|---|
| Melatonin Group | Active comparator | a 6 mg sublingual tablet of melatonin will be administered for all patients at 60 minutes before surgery. Receives: Drug: Sublingual Melatonin |
| Placebo Group | Placebo comparator | the participants will be received a visually identical tablet containing inert ingredients at 60 minutes before surgery. Receives: Drug: Sublingual Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
perioperative anxiety
It will be assessed using the Visual Analog Scale (VAS) for anxiety (0-10 cm) upon arrival to the operating room.
Measured: at 30 and 60 minutes before procedure, with application of local anesthesia, 15 and 30 minutes after anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Sep 2025
- Primary completion15 May 2026 (estimated)
- Study completion15 Jun 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 Cataract Surgery AnesthesiaStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
- Investigators
- Neveen A Kohaf, PhD, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036367
- Sponsor's protocol ID
- 33/2025
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principal investigator.
Publications
Wahane VD. A comparison of Gabapentin and melatonin for cataract surgery. Journal of Advanced Medical and Dental Sciences Research. 2017;5(8).
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Sublingual Melatonin Premedication in Geriatric Cataract Surgery
- ClinicalTrials.gov ID
- NCT07036367
- Acronym / sponsor ID
- 33/2025
- Conditions
- Cataract Surgery Anesthesia
- Keywords
- Melatonin, Geriatric, Cataract Surgery, Premedication, Sedation, anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 25 Jun 2025 (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.
Cataract surgery is routinely performed with anesthesia care, whereas anesthesia care for other elective, low-risk, outpatient procedures is applied more selectively. We hypothesize that sublingual melatonin will provide superior anxiolysis and sedation while maintaining a high safety profile and minimizing hemodynamic disturbances.
Detailed description
Prevalence of anesthesia care during cataract surgery compared with other low-risk procedures; association of anesthesia care with patient, clinician, and health system characteristics; and proportion of patients experiencing a significant anxiety and hemodynamic instability during cataract surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin Group | Active comparator | Drug: Sublingual Melatonina 6 mg sublingual tablet of melatonin will be administered for all patients at 60 minutes before surgery. |
| Placebo Group | Placebo comparator | Drug: Sublingual Placebothe participants will be received a visually identical tablet containing inert ingredients at 60 minutes before surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age ≥ 60 years
Key exclusion criteria (5 listed)
- • Known allergy or hypersensitivity to melatonin
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 |
|---|---|---|
| Sublingual MelatoninParticipants in this group received 3 mg of sublingual melatonin, administered 60 minutes before cataract surgery. The melatonin was given in the form of a rapidly dissolving sublingual tablet to enhance bioavailability and ensure consistent preoperative absorption. The goal of the intervention was to reduce preoperative anxiety, improve sedation level, and stabilize hemodynamic parameters. The melatonin tablets were indistinguishable in appearance from the placebo and were prepared and dispensed by a pharmacy technician not involved in data collection or patient care | Drug | Melatonin Group |
| Sublingual PlaceboParticipants in this group received an identical-appearing sublingual placebo tablet containing inert ingredients, administered 60 minutes before cataract surgery. The placebo was visually indistinguishable from the melatonin tablets and was used to maintain double blinding in the trial. Tablets were prepared by the pharmacy team to ensure concealment and eliminate bias. This group was designed to serve as a control to evaluate the effectiveness of sublingual melatonin on anxiety and sedation levels in elderly patients | Drug | Placebo Group |
Primary outcome
perioperative anxiety
Time frame: at 30 and 60 minutes before procedure, with application of local anesthesia, 15 and 30 minutes after anesthesia.
It will be assessed using the Visual Analog Scale (VAS) for anxiety (0-10 cm) upon arrival to the operating room.
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 7 Jan 2026.
- BackgroundWahane VD. A comparison of Gabapentin and melatonin for cataract surgery. Journal of Advanced Medical and Dental Sciences Research. 2017;5(8).
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principal investigator.
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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.
Neveen A Kohaf, PhD principal investigator
Al-Azhar University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sublingual Melatonin in people with Cataract Surgery Anesthesia, run by Al-Azhar University at 2 sites in 2 countries.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 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 2 sites in Egypt, Iraq. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Neveen A Kohaf, PhD (+201060383012, nevenabdo@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perioperative anxiety (time frame: at 30 and 60 minutes before procedure, with application of local anesthesia, 15 and 30 minutes after anesthesia.). 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 NCT07036367, 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 7 Jan 2026.