Rapid Sequence Intubation With Rocuronium in Elderly Patients

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rocuronium; Rapid Sequence Induction; Rapid Sequence Intubation
• Intervention / Treatment: Device: Train of four(TOF)

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadide Aysun Postacı; Phone Number: +905323520383; Email: aysunposta@yahoo.com

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ideal Body weight; ROCURONIUM PRIMING DOSE 0,06 MG/KG FOR IDEAL BODY WEIGHT BEFORE 3 MINUTES BEFORE INDUCTION. AFTER INDUCTION, ROCURONIUM 0,94 MG/KG FOR IDEAL BODY WEIGHT WILL BE GIVEN.	Device: Train of four(TOF); Train of four(TOF) monitoring after anesthesia induction
Active Comparator: Total Body Weight; ROCURONIUM PRIMING DOSE 0,06 MG/KG FOR TOTAL BODY WEIGHT BEFORE 3 MINUTES BEFORE INDUCTION. AFTER INDUCTION, ROCURONIUM 0,94 MG/KG FOR TOTAL BODY WEIGHT WILL BE GIVEN.	Device: Train of four(TOF); Train of four(TOF) monitoring after anesthesia induction
Active Comparator: Corrected Body Weight; ROCURONIUM PRIMING DOSE 0,06 MG/KG FOR CORRECTED BODY WEIGHT BEFORE 3 MINUTES BEFORE INDUCTION. AFTER INDUCTION, ROCURONIUM 0,94 MG/KG FOR CORRECTED BODY WEIGHT WILL BE GIVEN.	Device: Train of four(TOF); Train of four(TOF) monitoring after anesthesia induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
TOF value during intubation procedure	Train of four monitoring during induction and intubation	During intubation from start to finish of the study
Time to TOFR equal to zero	Time from rocuronium induction to TOFR equal to zero	During intubation from start to finish of the study
Time to TOFC equal to 1	Time from rocuronium induction to TOFc equal to 1	During intubation from start to finish of the study

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Nadide Aysun Postacı, aysunposta@yahoo.com

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Geriatrics; Rocuronium; Rapid Sequence Intubation; Rapid Sequence Induction and Intubation
• Other Study ID Numbers: E1-21-1849

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