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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Block Prolonged
• Intervention / Treatment: Device: Randomize clinical trial using hand dynamometer

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammed abdulzahra sasaa, phd; Phone Number: AZ 009647718991533; Email: m.abedalzahraa@alsafwa.edu.iq
• Study Contact Backup: Name: ahmed AD sahib, phd; Phone Number: 009647815759208; Email: smralmmwry@gmail.com

Study Locations

• Iraq
  • Adala
    • Najaf, Adala, Iraq, 54001
      • Recruiting
      • mohammed abdulzahra Sasaa
      • Contact: ahmed AD sahib, phd; Phone Number: 009647815759208; Email: smralmmwry@gmail.com
      • Contact: mohammed AZ sasaa, phd; Phone Number: 009647718991533; Email: m.abedalzahraa@alsafwa.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Atracrium group	Device: 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.
Other: Rocoronium group	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Al Safwa University College

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): August 10, 2023

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: December 11, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: hand dynamometer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No