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

NCT05657756 | Unknown DMC

• 1 other identifier: hand dynamometer
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Block Prolonged

Outcome Measures

Primary Outcomes (1)

• 100 patients were enrolled in our study, they are receiving muscle relaxants either Atracurium or rocuronium, and we recorded the muscle strength of the forearm in a postoperative location using an electronic hand dynamometer with a kilogram scale.

  record the neuromuscular recovery using a hand dynamometer with a kilogram scale

  up to 6 months

Study Arms (2)

Atracrium group

OTHER

Device: Randomize clinical trial using hand dynamometer

Rocoronium group

OTHER

Device: Randomize clinical trial using hand dynamometer

Interventions

Randomize clinical trial using hand dynamometer 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.

Atracrium group; Rocoronium group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al Safwa University College: lead

Study Sites (1)

mohammed abdulzahra Sasaa

Najaf, Adala, 54001, Iraq

RECRUITING

Central Study Contacts

Mohammed abdulzahra sasaa, phd

CONTACT

009647718991533; m.abedalzahraa@alsafwa.edu.iq

Ahmed AD sahib, phd

CONTACT

009647815759208; smralmmwry@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 20, 2022
• Study Start: June 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 10, 2023
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)