Clinical trial NCT05067829: Rapid Sequence Intubation With Rocuronium in Elderly Patients
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rapid Sequence Induction
Rapid Sequence Intubation
Rocuronium
Keywords: Rapid Sequence Induction and Intubation
Rapid Sequence Intubation
Rocuronium
Geriatrics
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 75
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized contrrolled study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The percent of excellent intubation condition
timeFrame: During intubation from start to finish of the study
measure: TOF value during intubation procedure
timeFrame: During intubation from start to finish of the study
measure: Time to TOFR equal to zero
timeFrame: During intubation from start to finish of the study
measure: Time to TOFC equal to 1
timeFrame: During intubation from start to finish of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: aysunposta@yahoo.com
name: Nadide Aysun Postacı
role: PRINCIPAL_INVESTIGATOR
References: