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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

Tracking Information
First Submitted Date  ICMJE February 2, 2017
First Posted Date  ICMJE February 15, 2017
Results First Submitted Date  ICMJE November 7, 2017
Results First Posted Date  ICMJE January 19, 2018
Last Update Posted Date September 10, 2018
Actual Study Start Date  ICMJE May 3, 2016
Actual Primary Completion Date November 5, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
Surgical Conditions (see link to Study Protocol for Scale) [ Time Frame: Intraoperative ]
Scale of mobility of eye during surgery rate 0 (no movement) to 3 (movement enough to stop surgery)
Change History Complete list of historical versions of study NCT03054103 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
  • Patient Self-Assessment (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
  • 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.
  • 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 if they are experiencing any nausea just prior to discharge from the PACU (Recovery Room).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sedation Methods During Cataract Surgery
Official Title  ICMJE A Comparison of Midazolam vs. Midazolam/Ketamine for Conscious Sedation in Patients Undergoing Phacoemulsification Under Topical Anesthesia
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.

Detailed Description

Phacoemulsification is the most common surgical procedure performed in the United States and European Union. In addition, the number of diagnoses of cataracts is expected to double from 25,000,000 in 2010 to 50,000,000 in 2050 while the incidence of phacoemulsification is also increasing. Therefore, any attempt to optimize outcome and efficiency is significant.

Sedation is commonly used during phacoemulsification to help alleviate patient anxiety and prevent the patient from interfering with the procedure. However, a great deal of variation exists in anesthetic management of these cases. Investigators have published use of a number of agents for sedation in the literature. These include midazolam, clonidine, propofol, fentanyl, dexmedetomidine, remifentanil, and oral diazepam. Intravenous (IV) clonidine has a half-life of 9-13 h and increased risk of postoperative hypotension. Propofol causes disinhibition and it has to be titrated during surgery to prevent oversedation. Opioids carry an increased risk of respiratory depression, prolonged sedation, as well as delirium in the elderly. Finally, oral medications do not allow for quick dose adjustments during surgery.

Intravenous midazolam is commonly used for sedation during phacoemulsification and other minor procedures. It has properties as an anxiolytic, muscle relaxant, and it is effective at reducing intraocular pressure. However, anxious patients administered benzodiazepines may require higher doses during cataract surgery which can lead to oversedation or disinhibition with subsequent patient movement. These responses can reduce the patient's ability to follow simple commands which can affect surgical outcome. Additionally, patients who receive too much sedation may fall asleep and wake up startled, similarly compromising the outcome of the surgery.

In the search for additional medications that can improve surgical conditions and patient comfort during phacoemulsification, the investigators explored the use of a medication that can improve analgesia and reduce patient movement during procedures, namely ketamine. Ketamine is an NMDA antagonist with both sedative and analgesic properties and has minimal effects on respiration. Ketamine has been used to premedicate and sedate patients undergoing day care procedures without adverse effects, and patients, typically, remain cooperative albeit being sedated. These properties along with its relatively short elimination half-life of 2 h (compared with 3-4 h for midazolam) make ketamine an attractive agent for sedation during monitored anesthesia care (MAC) for cataract surgery.

The purpose of this study was 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 IV conscious sedation.

The investigators measured the surgeon's assessment of the participant's cooperation during surgery according to a predetermined Likert scale. The investigators also recorded the following outcome measures regarding each participant's surgery: 1) total dose of midazolam, 2) average time spent in the procedural room, 3) postoperative length of stay (LOS), and 4) average postoperative pain score. The subjects received a survey inquiring about the subjects' comfort and sedation level during surgery. Finally, the investigators recorded the following demographic data for all participants: gender, age, psychiatric diagnoses, and use of CNS, psychiatric, or opioid medications.

Statistical Analysis The investigators used Fisher's exact test for examining data expressed as percentages, and Students t-test for yes/no data, and repeated measures ANOVA for 3 group analysis (LOS, surgical duration). The investigators judged significance at a P-value of 0.05. The investigators utilized a generalized estimated equations (GEE) to fit a logistic model to assess differences in the responses of patients based on amount of ketamine received. The GEE approach can fit models to correlated outcomes, as in the case where subjects had more than one procedure performed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Phacoemulsification
  • Cataract
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Midazolam alone
    Drug: Midazolam titrated 0.5-2.0 mg + normal saline placebo. Midazolam + Normal saline
    Intervention: Drug: Midazolam + Normal saline
  • 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
    Intervention: Drug: Midazolam + Ketamine 10 MG/ML: 0.5 ML
  • 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
    Intervention: Drug: Midazolam + Ketamine 10 MG/ML: 1 ML
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2017)
105
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 11, 2016
Actual Primary Completion Date November 5, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03054103
Other Study ID Numbers  ICMJE IRB00031444
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Timothy N Harwood, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP