Rapid Sequence Intubation With Rocuronium in Elderly Patients

Rocuronium Clinical Trial

Official title:

Comparison of the Effect of Rocuronium Dosing Based on Ideal, Corrected or Total Body Weight on Rapid Sequence Intubation With Priming on Neuromuscular Blockage and Intubation Condition in Elderly Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05067829
• Other study ID #: E1-21-1849
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Ankara City Hospital Bilkent
• Contact: Nadide Aysun Postaci
• Phone: +905323520383
• Email: aysunposta[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the prolongation of life expectancy, the frequency of surgical intervention and anesthesia increases in elderly patients. The rapid Sequence Intubation(RSI) technique is preferred in patients with aspiration risk and who will undergo general anesthesia, especially in the pandemic period, to reduce or eliminate the aerosolization of respiratory secretions. The use of rocuronium at a dose of 1 mg/kg in RSI also causes prolongation of the recovery of neuromuscular block. This study aimed to compare the intubation conditions and train-of-four count(TOFC) 1-2 times of the rocuronium doses with priming according to ideal body weight(IBW), corrected body weight(CBW), and total body weight(TBW) in RSI of patients aged >65 years.

Description:

The number of elderly patients (>65 y) increases, and a large proportion of these patients will require surgery and anesthesia at some point. Changes in the neuromuscular junction, organ systems, and cardiac output that occur with aging cause changes in response to neuromuscular blockers. One of the reasons for rapid sequence intubation(RSI) preference is to reduce or eliminate aerosolization of respiratory secretions during general anesthesia and airway manipulation in surgical cases during the pandemic period. Guidelines regarding this subject recommend securing the airway quickly with RSI, and it is reported that aerosol production would decrease with this method. This study aimed to compare the intubation conditions and the train-of-four count (TOFC) 1 and 2 response times of the patients aged 65 and above, who were administered rocuronium at a priming dose (0.06 mg/kg) according to ideal body weight(IBW), corrected body weight(CBW), and total body weight (TBW) before induction, followed by administration of 0.94 mg/kg rocuronium 3 minutes after the anesthesia induction and intubated 45 seconds later.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• Elective abdominal surgery
• Age > 65 years
• ASA I-II -III

Exclusion Criteria:

• Patient with history of allergy to rocuronium
• Body Mass Index > 35 kg/m2
• Patient who had history of difficult intubation or high possibility of difficult intubation
• Neuromuscular disease
• Kidney failure (GFR < 30 ml/dk/m2)

Related Conditions & MeSH terms

• Rapid Sequence Induction
• Rapid Sequence Intubation
• Rocuronium

Intervention

Device:
• Train of four(TOF)
Train of four(TOF) monitoring after anesthesia induction

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent of excellent intubation condition	Score 1: Poor jaw relaxation/ Active resistance to blade/closing vokal kord/ Severe coughing or bucking/ Vigorous limb movement Score 2: Acceptable jaw relaxation/ Intermediate vokal cord moving/ slight limb and diaphram movement score 3: relaxed laryngoscopy/ abducted vocal cords/ no limb and diphragm movement	During intubation from start to finish of the study
Primary	TOF value during intubation procedure	Train of four monitoring during induction and intubation	During intubation from start to finish of the study
Primary	Time to TOFR equal to zero	Time from rocuronium induction to TOFR equal to zero	During intubation from start to finish of the study
Primary	Time to TOFC equal to 1	Time from rocuronium induction to TOFc equal to 1	During intubation from start to finish of the study