Rapid Sequence Intubation With Rocuronium in Elderly Patients

• Sponsor: Ankara City Hospital Bilkent (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05067829
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 14.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rapid Sequence Induction; Rapid Sequence Intubation; Rocuronium	Device: Train of four(TOF)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective randomized contrrolled studyProspective randomized contrrolled study
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. TOF value during intubation procedure [During intubation from start to finish of the study]

   Train of four monitoring during induction and intubation

3. Time to TOFR equal to zero [During intubation from start to finish of the study]

   Time from rocuronium induction to TOFR equal to zero

4. 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 Criteria

Criteria

• Ages Eligible for Study: 65 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ankara City Hospital	Ankara		Turkey	06800

Sponsors and Collaborators

• Ankara City Hospital Bilkent

Investigators

• Principal Investigator: Nadide Aysun Postacı, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: aysun postaci, Associate Prof. Dr, Ankara City Hospital Bilkent
• ClinicalTrials.gov Identifier: NCT05067829
• Other Study ID Numbers: E1-21-1849
• First Posted: Oct 5, 2021
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by aysun postaci, Associate Prof. Dr, Ankara City Hospital Bilkent: Rapid Sequence Induction and Intubation; Rapid Sequence Intubation; Rocuronium; Geriatrics

Study Results

No Results Posted as of May 26, 2022