Rapid Sequence Intubation With Rocuronium in Elderly Patients

Not Applicable

• Conditions: Rapid Sequence Intubation; Rocuronium; Rapid Sequence Induction

• Registration Number: NCT05067829
• Lead Sponsor: Ankara City Hospital Bilkent

Brief 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.

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 Timeline

• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-10-05
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-26
• Study Start: 2022-07-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to TOFC equal to 1	During intubation from start to finish of the study	Time from rocuronium induction to TOFc equal to 1
TOF value during intubation procedure	During intubation from start to finish of the study	Train of four monitoring during induction and intubation
Time to TOFR equal to zero	During intubation from start to finish of the study	Time from rocuronium induction to TOFR equal to zero
The percent of excellent intubation condition	During intubation from start to finish of the study	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

Trial Locations

Locations (1)

Ankara City Hospital; 🇹🇷 Ankara, Turkey