Rapid Sequence Intubation With Rocuronium in Elderly Patients

NCT05067829 — Not applicable, Unknown, 75 participants, Ankara City Hospital Bilkent

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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.

Registry	NCT05067829
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	75 (Estimated)
Sponsor	Ankara City Hospital Bilkent (Other)
Conditions	Rapid Sequence Induction, Rapid Sequence Intubation, Rocuronium
Interventions	Train of four(TOF) (Device)
Dates	start 2022-07-01 (estimated), primary completion 2022-09-30 (estimated), completion 2022-12-01 (estimated), first posted 2021-10-05, last updated 2022-05-26
Locations	1 site in Turkey (Türkiye)

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Ideal Body weight	Active comparator	Device: Train of four(TOF)	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.
Total Body Weight	Active comparator	Device: Train of four(TOF)	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.
Corrected Body Weight	Active comparator	Device: Train of four(TOF)	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.

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

+Outcome measures

Primary outcomes

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
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
Time to TOFC equal to 1 [During intubation from start to finish of the study]: Time from rocuronium induction to TOFc equal to 1

+Eligibility

Sex: Female, ages: 65 Years to 100 Years

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)

+Locations (1)

Facility	City	Country	Status
Ankara City Hospital	Ankara	Turkey (Türkiye)

+Investigators

Nadide Aysun Postacı, Principal investigator, aysunposta@yahoo.com