Hand Dynamometer and Clinical Tests to Evaluate Neuromuscular Recovery in Atracurium vs Rocuronium

NCT ID: NCT05657756

Last Updated: 2022-12-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-08-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

One of the common serious complications in the postoperative phase is Residual the neuromuscular blockade that confused the anesthesia medical team also patients may become uncomfortable, un ability to clear secretion, un-explanation of decreasing SPO2, increase respiratory effort and lead to an increase in the risk of respiratory complication. Most clinicians used clinical assessment to evaluate neuromuscular recovery such as a head lift for 5 seconds, Sustain leg lift, Tongue protrusion, teeth clenching, swallowing, Tidal volume 5 mL/kg, Handgrips Sustained for 5 seconds, and other clinical assessments in patients undergoing general anesthesia. A few studies have been discussing the utilization of hand dynamometers in the assessment of post-residual neuromuscular block. Our aim is to examine the neuromuscular recovery using a hand dynamometer after receiving Atracurium versus Rocuronium.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuromuscular Block Prolonged

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Atracrium group

Group Type OTHER

Randomize clinical trial using hand dynamometer

Intervention Type DEVICE

Our research article involves 100 patients aged over 18 years old with ASAI\&II divided into two groups, 50 patients will receive atracurium (0.5 mg/kg) and 30 patients receive Rocuronium (0.6 mg/kg). All of our patients will be undergoing elective laparoscopic surgery for cholecystectomy; the patients will randomly select to receive standard anesthesia induction with propofol (2 mg/kg), fentanyl (1-2 mcg/kg), and isoflurane 1.2 Mac, except muscle relaxant. Neuromuscular will monitoring by Train-of-Four (TOF) during surgery.

Rocoronium group

Group Type OTHER

Randomize clinical trial using hand dynamometer

Intervention Type DEVICE

Our research article involves 100 patients aged over 18 years old with ASAI\&II divided into two groups, 50 patients will receive atracurium (0.5 mg/kg) and 30 patients receive Rocuronium (0.6 mg/kg). All of our patients will be undergoing elective laparoscopic surgery for cholecystectomy; the patients will randomly select to receive standard anesthesia induction with propofol (2 mg/kg), fentanyl (1-2 mcg/kg), and isoflurane 1.2 Mac, except muscle relaxant. Neuromuscular will monitoring by Train-of-Four (TOF) during surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Randomize clinical trial using hand dynamometer

Our research article involves 100 patients aged over 18 years old with ASAI\&II divided into two groups, 50 patients will receive atracurium (0.5 mg/kg) and 30 patients receive Rocuronium (0.6 mg/kg). All of our patients will be undergoing elective laparoscopic surgery for cholecystectomy; the patients will randomly select to receive standard anesthesia induction with propofol (2 mg/kg), fentanyl (1-2 mcg/kg), and isoflurane 1.2 Mac, except muscle relaxant. Neuromuscular will monitoring by Train-of-Four (TOF) during surgery.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* all patient between 18-60 years old with ASAII under general anesthesia

Exclusion Criteria

* all patient under 18 years old and over 60 years old
* prior administration of suxamethonium
* patient received magnesium, lithium, Quinidine, calcium channel blockers, local anesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Al Safwa University College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammed AbdulZahra Sasaa

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

mohammed abdulzahra Sasaa

Najaf, Adala, Iraq

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Iraq

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohammed abdulzahra sasaa, phd

Role: CONTACT

Phone: 009647718991533

Email: [email protected]

Ahmed AD sahib, phd

Role: CONTACT

Phone: 009647815759208

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

mohammed AZ sasaa, phd

Role: primary

ahmed AD sahib, phd

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

hand dynamometer

Identifier Type: -

Identifier Source: org_study_id