Rapid Sequence Intubation With Rocuronium in Elderly Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Rocuronium, Rapid Sequence Induction, Rapid Sequence Intubation

Intervention / Treatment
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* Device: Train of four(TOF)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized contrrolled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ideal Body weight<br>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)<br>* Train of four(TOF) monitoring after anesthesia induction<br>|
| Active Comparator: Total Body Weight<br>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)<br>* Train of four(TOF) monitoring after anesthesia induction<br>|
| Active Comparator: Corrected Body Weight<br>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)<br>* Train of four(TOF) monitoring after anesthesia induction<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rapid Sequence Induction and Intubation, Rapid Sequence Intubation, Rocuronium, Geriatrics