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Sedation Methods During Cataract Surgery

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ClinicalTrials.gov Identifier: NCT03054103
Recruitment Status : Completed
First Posted : February 15, 2017
Results First Posted : January 19, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.


Condition or disease Intervention/treatment Phase
Phacoemulsification Cataract Drug: Midazolam + Ketamine 10 MG/ML: 0.5 ML Drug: Midazolam + Ketamine 10 MG/ML: 1 ML Drug: Midazolam + Normal saline Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled, double-masked, three-armed clinical comparison
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Surgical conditions and patient response not aware of medication given.
Primary Purpose: Treatment
Official Title: A Comparison of Midazolam vs. Midazolam/Ketamine for Conscious Sedation in Patients Undergoing Phacoemulsification Under Topical Anesthesia
Actual Study Start Date : May 3, 2016
Actual Primary Completion Date : November 5, 2016
Actual Study Completion Date : November 11, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Placebo Comparator: Midazolam alone
Drug: Midazolam titrated 0.5-2.0 mg + normal saline placebo. Midazolam + Normal saline
Drug: Midazolam + Normal saline
Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.
Other Name: NS

Active Comparator: Midazolam + Ketamine 5 mg
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
5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.
Other Name: Ketalar

Active Comparator: Midazolam + Ketamine 10 mg
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
10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.
Other Name: Ketalar




Primary Outcome Measures :
  1. Eye Mobility During Surgery (See Link to Study Protocol for Scale) [ Time Frame: Intraoperative, end of operation reported ]
    Scale of mobility of eye during surgery rate 0 (no movement) to 3 (movement enough to stop surgery).


Secondary Outcome Measures :
  1. Measure of Comfort (See Link to Study Protocol for Scale) [ Time Frame: Obtained on the first day after surgery during the subject's routine postoperative check in the Ophthalmology Clinic. ]
    Measure of comfort (0-3; 0=very comfortable to 3=extremely uncomfortable

  2. PACU Length of Stay [ Time Frame: This will occur one time only, in a range of 20 to 30 minutes after the surgery is completed. ]
    This is obtained from the records as time spent in the PACU (Recovery Room) after surgery.

  3. Nausea [ Time Frame: 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. ]
    Self-reported incidence of nausea. This will be assessed by asking the subjects once (just prior to discharge from the PACU) whether they experienced any nausea while they were in the PACU (Recovery Room) and will be a measurement of the count of participants that experienced nausea during this period



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients met inclusion criteria if they were between 18- and 80-years-old and undergoing elective cataract surgery performed by a single ophthalmologist (KW).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054103


Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Timothy N Harwood, MD Wake Forest University Health Sciences

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03054103     History of Changes
Other Study ID Numbers: IRB00031444
First Posted: February 15, 2017    Key Record Dates
Results First Posted: January 19, 2018
Last Update Posted: September 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Wake Forest University Health Sciences:
ketamine
midazolam
sedation
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Midazolam
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents