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Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy

NCT ID: NCT03775876

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-09-15

Brief Summary

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Operative shoulder arthroscopy under regional block anesthesia often presents with hemodynamic challenges for the anesthesiologist, knowing that a low systolic blood pressure is required to minimize the bleeding. Regional anesthesia is successfully performed to many patients in whom tracheal intubation or the placement of a laryngeal tube is undesired. Propofol has traditionally been used to provide sedation in patients undergoing shoulder arthroscopy under regional anesthesia. In contrast to Propofol, Dexmedetomidine is a highly selective α-2 adrenoceptor agonist that has been shown to provide sedation, analgesia and anxiolytic effects with minimal respiratory depression. Due to the effect of both drugs on blood pressure, the investigators set out to compare intraoperative hemodynamics of both drugs, along with the surgeon's satisfaction and the degree of comfort provided to patients undergoing interscalene brachial plexus block for shoulder arthroscopy. The investigators also assessed whether the type of anesthetic agent used for sedation accounted for other differences in intra and post-operative outcome measures.

Detailed Description

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Conditions

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Hemodynamic Sedation Satisfaction, Personal

Keywords

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Propofol Dexmedetomidine Regional anesthesia Satisfaction Shoulder arthroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised controlled double blind trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
surgeons, patients as well as the outcome assessor were blinded in regards of the drug used for sedation during surgery (Propofol vs dexmedetomidine)

Study Groups

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Propofol

Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Propofol. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 2mg/Kg/h and modified to a maximum of 4 mg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four.

Group Type ACTIVE_COMPARATOR

Shoulder Arthroscopy

Intervention Type PROCEDURE

patients in both groups are programmed for an elective shoulder arthroscopy surgery

Regional Block

Intervention Type PROCEDURE

patients in both groups received regional block for anesthesia: brachial plexus blockade was performed using the interscalene approach under ultrasound combined to nerve stimulation. 20 ml ropivacaine 0.375% were injected.

Propofol

Intervention Type DRUG

propofol 10mg/ml was used for sedation as described in the arms section

BIS

Intervention Type DIAGNOSTIC_TEST

sedation level was monitored using bispectral index to achieve values described in the arms group

Dexmedetomidine

Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Dexmedetomidine. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 1mcg/kg over 10 minutes then 0.2 mcg/Kg/h and modified to a maximum of 0.7 mcg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four with a maximum.

Group Type ACTIVE_COMPARATOR

Shoulder Arthroscopy

Intervention Type PROCEDURE

patients in both groups are programmed for an elective shoulder arthroscopy surgery

Regional Block

Intervention Type PROCEDURE

patients in both groups received regional block for anesthesia: brachial plexus blockade was performed using the interscalene approach under ultrasound combined to nerve stimulation. 20 ml ropivacaine 0.375% were injected.

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section

BIS

Intervention Type DIAGNOSTIC_TEST

sedation level was monitored using bispectral index to achieve values described in the arms group

Interventions

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Shoulder Arthroscopy

patients in both groups are programmed for an elective shoulder arthroscopy surgery

Intervention Type PROCEDURE

Regional Block

patients in both groups received regional block for anesthesia: brachial plexus blockade was performed using the interscalene approach under ultrasound combined to nerve stimulation. 20 ml ropivacaine 0.375% were injected.

Intervention Type PROCEDURE

Propofol

propofol 10mg/ml was used for sedation as described in the arms section

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section

Intervention Type DRUG

BIS

sedation level was monitored using bispectral index to achieve values described in the arms group

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Surgery Interscalene brachial plexus block Propofol-Lipuro Dexmedetomidine Hcl 100 mcg (Micrograms)/ml Inj Bispectral index

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists score (ASA) I or II.
* Elective Shoulder arthroscopy.

Exclusion Criteria

* Allergies to any of the used medications.
* ASA score of III or above.
* Cardiac abnormalities.
* Contraindications to regional blocks.
* Patient refusal.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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Hicham Abou Zeid

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hicham A ABOU ZEID, M.D., M.Sc.

Role: STUDY_CHAIR

Saint Joseph University School of Medicine

Nouhad S AYOUB, M.D.

Role: PRINCIPAL_INVESTIGATOR

Saint Joseph University School of Medicine

Locations

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Hotel Dieu de France Hospital

Beirut, , Lebanon

Site Status

Countries

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Lebanon

References

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Peng K, Li J, Ji FH, Li Z. Dexmedetomidine compared with propofol for pediatric sedation during cerebral angiography. J Res Med Sci. 2014 Jun;19(6):549-54.

Reference Type BACKGROUND
PMID: 25197298 (View on PubMed)

Kim N, Yoo YC, Lee SK, Kim H, Ju HM, Min KT. Comparison of the efficacy and safety of sedation between dexmedetomidine-remifentanil and propofol-remifentanil during endoscopic submucosal dissection. World J Gastroenterol. 2015 Mar 28;21(12):3671-8. doi: 10.3748/wjg.v21.i12.3671.

Reference Type BACKGROUND
PMID: 25834336 (View on PubMed)

Wu Y, Zhang Y, Hu X, Qian C, Zhou Y, Xie J. A comparison of propofol vs. dexmedetomidine for sedation, haemodynamic control and satisfaction, during esophagogastroduodenoscopy under conscious sedation. J Clin Pharm Ther. 2015 Aug;40(4):419-25. doi: 10.1111/jcpt.12282. Epub 2015 May 13.

Reference Type BACKGROUND
PMID: 25970229 (View on PubMed)

Other Identifiers

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CEHDF 945

Identifier Type: -

Identifier Source: org_study_id