Rapid Sequence Intubation With Rocuronium in Elderly Patients

NCT05067829 | Unknown

• 1 other identifier: E1-21-1849
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Rapid Sequence Induction; Rapid Sequence Intubation; Rocuronium

Keywords

Rapid Sequence Induction and Intubation; Rapid Sequence Intubation; Rocuronium; Geriatrics

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Ideal Body weight

ACTIVE COMPARATOR

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)

Total Body Weight

ACTIVE COMPARATOR

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)

Corrected Body Weight

ACTIVE COMPARATOR

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)

Interventions

Train of four(TOF) DEVICE

Train of four(TOF) monitoring after anesthesia induction

Corrected Body Weight; Ideal Body weight; Total Body Weight

Eligibility Criteria

• Age: 65 Years - 100 Years
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Elective abdominal surgery
• Age \> 65 years
• ASA I-II -III

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Neuromuscular Monitoring

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Nadide Aysun Postacı

  aysunposta@yahoo.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadide Aysun Postacı

CONTACT

+905323520383; aysunposta@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Prof. Dr

Model Details: Prospective randomized contrrolled study

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 5, 2021
• Study Start: July 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: December 1, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)