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

Sponsor

Al Safwa University College (Other)

Overall Status

Recruiting

CT.gov ID

NCT05657756

Collaborator

(none)

100

Enrollment

Location

Arms

2.3

Anticipated Duration (Months)

43.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Block Prolonged	Device: Randomize clinical trial using hand dynamometer	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 10, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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. [up to 6 months]
record the neuromuscular recovery using a hand dynamometer with a kilogram scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	mohammed abdulzahra Sasaa	Najaf	Adala	Iraq	54001

Sponsors and Collaborators

Al Safwa University College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohammed AbdulZahra Sasaa, principle investigator, Al Safwa University College

ClinicalTrials.gov Identifier:

NCT05657756

Other Study ID Numbers:

hand dynamometer

First Posted:

Dec 20, 2022

Last Update Posted:

Dec 20, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Study Results

No Results Posted as of Dec 20, 2022