Dexmedetomidine vs Propofol TIVA (Total Intravenous Anesthesia) and Interscalene Block

NCT ID: NCT02469961

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-07-31

Brief Summary

The standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol.

The primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators will enroll 50 patients for this study.

Our hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and reduced need for supplemental medication for sedation, compared to Propofol

Detailed Description

The anesthesia provided during shoulder surgery commonly uses a combination of regional and intravenous (IV) anesthetic medications. The current drug of choice for IV sedation is Propofol. Although. it is a good anesthetic, incidence of intermittent apnea makes the use of it problematic in cases where the head of the patient is less accessible to the anesthesiologist, as is in sitting beach char position. Dexmedetomidine is a FDA approved drug, which has a very stable cardiovascular and respiratory profile. It has been successfully used for Neurological and Vascular cases and in Intensive care units. The primary objective of the present study is to use Dexmedetomidine for sedation, and compare the outcomes with Propofol sedation. The investigators' will enroll 50 patients for this study. Using a computer program the participants will be randomized into two equal groups to receive either Dexmedetomidine or Propofol.

The standard hospital procedure calls for the patient to undergo Interscalene block under ultrasound with or without nerve stimulation guidance prior to going to operating room (OR). The block utilizes a 40 ml mixture of 0.5% Ropivacaine and Lidocaine 1.5%. At this time the patient receives preliminary sedation with Midazolam 1mg IV and Fentanyl 50 mcg IV. The participant is then brought to the OR and prolonged sedation is initiated, randomly using either Dexmedetomidine or Propofol.

Dexmedetomidine infusion is initiated with a bolus of 1 mcg/kg is given over 10 min as patient is being positioned, and the sedation is maintained with Dexmedetomidine at 0.7- 1.0 mcg/kg/hr during the surgery. Propofol infusion is started at 100mcg/kg/min, and maintained with Propofol at 50-120mcg/kg/min, during the surgery.

In each group the investigators will record the incidence of respiratory depression/hypoxia, hemodynamic stability, frequency of airway manipulation, cardiovascular effects, need for anesthetic supplementation of Dexmedetomidine, post anesthesia care unit (PACU) discharge time, the need for postoperative pain medication, post operative complications, like nausea/vomiting.

Significant differences between the two groups will be evaluated using unpaired t-test for numerical variables, and Chi-square test or Z test for categorical variables.

The investigators hypothesis is that Dexmedetomidine will cause fewer episodes of intermittent apnea, and reduced need for supplemental medication for sedation, compared to Propofol

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

dexmedetomidine

Participants will receive an interscalene block and be sedated with dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol

Interscalene block

Intervention Type: OTHER

Interscalene block is used for the main anesthetic for the case

Propofol

Participants will receive an interscalene block and be sedated with propofol

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine

Interscalene block

Intervention Type: OTHER

Interscalene block is used for the main anesthetic for the case

Interventions

Dexmedetomidine

Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol

Intervention Type: DRUG

Propofol

Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine

Intervention Type: DRUG

Interscalene block

Interscalene block is used for the main anesthetic for the case

Intervention Type: OTHER

Other Intervention Names

precedex; diprivan

Eligibility Criteria

Inclusion Criteria

Participants scheduled for shoulder arthroscopies in the beach chair sitting position.

Participants who received a successful interscalene block.

Exclusion Criteria

Failed interscalene block. Refusal to participate in the study. Allergy to the study drugs. Participants that need a secure airway.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maimonides Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Piyush Gupta, MD

Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

piyush Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

References

Mehta PP, Kochhar G, Kalra S, Maurer W, Tetzlaff J, Singh G, Lopez R, Sanaka MR, Vargo JJ. Can a validated sleep apnea scoring system predict cardiopulmonary events using propofol sedation for routine EGD or colonoscopy? A prospective cohort study. Gastrointest Endosc. 2014 Mar;79(3):436-44. doi: 10.1016/j.gie.2013.09.022. Epub 2013 Nov 9.

Reference Type: RESULT

PMID: 24219821 (View on PubMed)

Venn RM, Hell J, Grounds RM. Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care. Crit Care. 2000;4(5):302-8. doi: 10.1186/cc712. Epub 2000 Jul 31.

Reference Type: RESULT

PMID: 11056756 (View on PubMed)

Other Identifiers

10/07/VA07

Identifier Type: -

Identifier Source: org_study_id