Exploring Sedation Types During Cataract Surgery

NCT04725747 | Completed FDA Drug

• 1 other identifier: MAKER
• Study Type: observational
• Target: 1,111
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to explore the sedative and analgesic effectiveness of the Midazolam/Ketamine melt compared to IV sedation in subjects undergoing intraocular surgery.

Conditions

Vital Signs

Outcome Measures

Primary Outcomes (3)

• Level of Sedation

  The Doctor/Nurse Anesthetist will evaluate the subject's level of sedation on the Ramsey Sedation Scale. Adequate sedation demonstrated by a score of 2 or higher on the Ramsey Scale: * Upon entering operative room (before being prepped and draped) * Immediately post-op upon entering the PACU The Ramsey scale is: 1. Patient is anxious and agitated or restless, or both 2. Patient is co-operative, oriented, and tranquil 3. Patient responds to commands only 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6. Patient exhibits no response Source: Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxolone-alphadalone. BMJ. 1974;2:656-659.

  Duration of surgery

• Level of Pain

  Adequate pain control demonstrated by a score of 3 or below on the Numeric Pain Rating Scale (NPRS) by asking the following questions at the following times: 1. "How painful was that on a scale of 0=no pain to 10=extreme pain?" will be asked: * Upon insertion of the speculum * Upon first incision * Upon insertion of phacoemulsification probe * Upon Lens insertion * Upon removal of sterile drape 2. "How would you rate your worst pain during surgery on a scale of 0=no pain to 10=extreme pain?" will be asked: * Immediately after surgery in the OR * 10-15 mins after the subject reaches the PACU 3. "On a scale of 0=no pain to 10=extreme pain what number best describes your overall pain during the surgery?" Will be asked: * Immediately after surgery in the OR * 10-15 mins after the subject reaches the PACU

  Duration of surgery

• Need for Rescue Medication

  Percentage of patients requiring rescue medication (IV Fentanyl) for pain. Rescue medication will only be giving if a subject reports a pain level of 4 or higher on the NPRS.

  Duration of surgery

Secondary Outcomes (3)

• Eye Movement During Surgery

  Duration of surgery

• Clinician's Global Impression

  Duration of surgery

• Patient Satisfaction

  1 day post operatively

Other Outcomes (2)

• Blood pressure changes

  Duration of surgery

• Heart rate changes

  Duration of surgery

Study Arms (1)

Cataract Surgery

Individuals undergoing cataract surgical intervention

Drug: Midazolam/Ketamine HCl 3mg-50mg sublingual; Drug: Intravenous Sedatives with or Without Analgesia

Interventions

Midazolam/Ketamine HCl 3mg-50mg sublingual DRUG

Single sublingual administration of Midazolam/Ketamine HCl 3mg-50mg sublingually prior to surgery

Cataract Surgery

Intravenous Sedatives with or Without Analgesia DRUG

Standard of Care

Also known as: IV Sedation

Cataract Surgery

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects requiring cataract removal

You may qualify if:

• Subjects must be male or female, and between the ages of 55-80 years old.
• Subjects willing and able to sign the informed consent and capable of committing to the duration of the study.
• Subjects undergoing uncomplicated stand-alone cataract surgery without planned use of Omidria or intra-operative lidocaine.
• Subjects that are willing to have an IV placed prior to intraocular surgery
• Subjects undergoing first eye cataract surgery
• Subjects that in the opinion of the investigator can tolerate 1 dose of MK 3/50 Melt.

You may not qualify if:

• Subjects who have undergone sedation in the past 90 days.
• Women who are pregnant or lactating at the time of the study.
• Subjects who do not wish to or cannot comply with study procedures.
• Subject with any cognitive impairment (i.e: Alzheimer's, dementia, etc.) that in the opinion of the investigator may confound the study results.
• Subjects with history of substance abuse.
• Subjects that are currently taking a prescription pain medication.
• Subjects that are not willing to abstain from all over-the-counter pain medication with the exception of 500-1000mg acetaminophen for 24 hours prior to surgery.
• Subjects that are not willing to abstain from NSAID or steroid eye drops prior to surgery.
• Subjects with planned use of femtosecond laser, zepto, iris hooks or a malyugin ring during cataract surgery.
• Subjects with chronic pain rated moderate to severe within the past week.
• Subjects that have a psychiatric disorder that is currently uncontrolled.
• Subjects scheduled for same day bilateral or second eye cataract surgery.

Sponsors & Collaborators

• Vance Thompson Vision: lead

Study Sites (2)

Vance Thompson Vision Clinic

Sioux Falls, South Dakota, 57108, United States

Location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Interventions

Midazolam; Ketamine; Analgesia

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anesthesia and Analgesia

Study Officials

• John Berdahl, MD

  Vance Thompson Vision Clinic Prof. LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: January 25, 2021
• Primary Completion: May 30, 2021
• Study Completion: June 30, 2021
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)