Sedation Methods During Cataract Surgery

NCT03054103 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00031444
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Phacoemulsification is the most common surgical procedure performed in the United States and European Union and sedation is commonly used during phacoemulsification to help alleviate patient anxiety and prevent the patient from interfering with the procedure. The investigators have administered ketamine in addition to midazolam in this regard. To study the effectiveness of this technique, The investigators proposed a study to determine if adding low-dose ketamine to midazolam has any beneficial (or negative) effects on operating conditions, patient satisfaction, and recovery during and after unilateral phacoemulsification procedures performed using topical anesthesia and intravenous (IV) conscious sedation. Methods: In a free-standing Outpatient Surgery Center, the investigators conducted a randomized, double-masked, 3-arm, prospective comparison of IV midazolam only vs. midazolam with ketamine 5 mg IV vs. midazolam with ketamine 10 mg IV. The investigators then measured a single surgeon's assessment of surgical conditions, self-reported patient satisfaction, postoperative pain score, and duration of postoperative stay. The investigators also analyzed the dose of midazolam required to meet subjective anxiolysis in each group.

Conditions

Phacoemulsification; Cataract

Keywords

ketamine; midazolam; sedation

Outcome Measures

Primary Outcomes (1)

• Eye Mobility During Surgery (See Link to Study Protocol for Scale)

  Scale of mobility of eye during surgery rate 0 (no movement) to 3 (movement enough to stop surgery).

  Intraoperative, end of operation reported

Secondary Outcomes (3)

• Measure of Comfort (See Link to Study Protocol for Scale)

  Obtained on the first day after surgery during the subject's routine postoperative check in the Ophthalmology Clinic.

• PACU Length of Stay

  This will occur one time only, in a range of 20 to 30 minutes after the surgery is completed.

• Nausea

  This will occur from time of entry into PACU to time of departure after their surgery. (One time only, in a range of 20 to 30 minutes after surgery.

Study Arms (3)

Midazolam alone

PLACEBO COMPARATOR

Drug: Midazolam titrated 0.5-2.0 mg + normal saline placebo. Midazolam + Normal saline

Drug: Midazolam + Normal saline

Midazolam + Ketamine 5 mg

ACTIVE COMPARATOR

Drug: Midazolam titrated 0.5-2.0 mg + Ketamine 10 MG/ML: 0.5 ML. Midazolam + Ketamine 10 MG/ML: 0.5 ML

Drug: Midazolam + Ketamine 10 MG/ML: 0.5 ML

Midazolam + Ketamine 10 mg

ACTIVE COMPARATOR

Drug: Midazolam titrated 0.5-2.0 mg + Ketamine 10 MG/ML: 1 ML. Midazolam + Ketamine 10 MG/ML: 1 ML

Drug: Midazolam + Ketamine 10 MG/ML: 1 ML

Interventions

Midazolam + Ketamine 10 MG/ML: 0.5 ML DRUG

5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.

Also known as: Ketalar

Midazolam + Ketamine 5 mg

Midazolam + Ketamine 10 MG/ML: 1 ML DRUG

10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.

Also known as: Ketalar

Midazolam + Ketamine 10 mg

Midazolam + Normal saline DRUG

Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.

Also known as: NS

Midazolam alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients younger than 18, older than 80, those with a serum creatinine \>3 mg/dl, advanced liver disease (liver enzymes twice the normal range or higher), and those with an allergy to any of the study medications were excluded from the study.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Cataract

Interventions

Midazolam; Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Study may be a bit underpowered for the small differences between groups in measured outcomes.

Results Point of Contact

• Title: Dr. Timothy Harwood
• Organization: Wake Forest University Health Sciences

tharwood@wakehealth.edu

3367164498

Study Officials

• Timothy N Harwood, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Surgical conditions and patient response not aware of medication given.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, double-masked, three-armed clinical comparison

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 15, 2017
• Study Start: May 3, 2016
• Primary Completion: November 5, 2016
• Study Completion: November 11, 2016
• Last Updated: September 10, 2018
• Results First Posted: January 19, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share