Rapid Sequence Intubation With Rocuronium-Sugammadex Compared With Succinylcholine

Rigshospitalet

Status and phase

Completed

Phase 4

Conditions

Rapid Sequence Intubation

Treatments

Drug: Succinylcholine

Drug: Rocuronium-Sugammadex

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00953550

1B-RSI-SU

Details and patient eligibility

About

Rapid sequence intubation is used, when there is an elevated risk of aspiration to the lungs of stomach content. It is typically used in acute settings that require acute surgery or in prehospital settings, but also in specific risk patients requiring elective surgery. The reason for conducting rapid sequence intubation is to minimize the risk of pulmonary aspiration and at the same time achieve a fast induction of anaesthesia and intubation. Rapid sequence intubation is a procedure with a high risk of complications in itself. The time period from induction of anaesthesia to intubation is particularly risky, because the patient is apneic. This study addresses this problem by investigating, how quickly spontaneous respiration can be reestablished after a rapid sequence intubation when using Rocuronium-Sugammadex compared to Succinylcholine. This is a pilot protocol that is intended to establish a sample size for the full protocol.

Study hypothesis: The time from correct tube placement to spontaneous respiration is shorter when using Rocuronium/Sugammadex compared to Succinylcholine.

Enrollment

61 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Elective surgical patients with a planned rapid sequence induction of anaesthesia.
Informed consent.
Legally competent.
Be able to understand Danish and be able to read the given information in Danish.
Females can only participate if they have reached menopause, have had hysterectomy performed, use a coil as birthcontrol, or if they are sterilized.

Exclusion criteria

Presence of kidney disease, defined as S-creatinine >0,200 mmol/L.
Known lung or heart disease, defined as NYHA-class >2 or CCS-class >2.
Known allergic reactions to Rocuronium, Suxamethon, Propofol or Sugammadex.
Contraindications to Suxamethon. Including raised P-potassium (>5,0 mmol/L), untreated glaucoma, neuromuscular disorders or disposition to malignant hyperthermia.
Body mass index of >35 kg/m2.
Pregnant.
Breastfeeding.