Trial Outcomes & Findings for Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients (NCT NCT01749631)

Results Overview

Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.

Recruitment status

COMPLETED

Target enrollment

97 participants

Primary outcome timeframe

Start of intubation to completion of intubation (up to 15 minutes)

Results posted on

2016-03-01

Participant Flow

A total of 97 participants were enrolled and included in the intent-to-treat (ITT) population; 1 participant did not meet the criteria Mallampati Score III or IV and was excluded from the per protocol population, which consisted of 96 participants.

Participant milestones

Participant milestones
Measure	Difficult to Intubate (DTI) Participants Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
Overall Study STARTED	97
Overall Study COMPLETED	97
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Difficult to Intubate (DTI) Participants n=96 Participants Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
Age, Continuous	48.8 years STANDARD_DEVIATION 15.04 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: Start of intubation to completion of intubation (up to 15 minutes)

Population: Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.

Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.

Outcome measures

Outcome measures
Measure	Difficult to Intubate (DTI) Participants n=96 Participants Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
Percentage of Participants With Successful Intubation (Clinical Success) Success	96.9 percentage of participants
Percentage of Participants With Successful Intubation (Clinical Success) Failure	3.1 percentage of participants

SECONDARY outcome

Timeframe: From start of induction up to 15 minutes

Population: Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.

The mean duration of induction (in seconds) was defined as the time required to reach a Ramsay Sedation Score (RSS) of 5 from start of induction. The RSS levels are defined as 1 = anxious, agitated or restless; 2 = calm, co-operative and communicative; 3 = response is quick to a voice command; 4 = response is slow to a voice command; 5 = slow or sluggish response; and 6 = no response at all.

Outcome measures

Outcome measures
Measure	Difficult to Intubate (DTI) Participants n=96 Participants Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
Mean Duration of Induction (in Seconds)	220.45 seconds Standard Error 23.43

SECONDARY outcome

Timeframe: Screening

Population: Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.

Mallampati classification correlates tongue size to pharyngeal size. The test is performed with the patient in the sitting position, head in a neutral position, the mouth wide open and the tongue protruding to its maximum, without phonation. Classification is assigned according to the extent the base of tongue is able to mask the visibility of pharyngeal structures: Class I = visualization of the soft palate, fauces; uvula, anterior and the posterior pillars; Class II = visualization of the soft palate, fauces and uvula; Class III = visualization of soft palate and base of uvula; and Class IV: only hard palate is visible, soft palate is not visible at all. A high score (Class III or IV) is associated with more difficult intubation.

Outcome measures

Outcome measures
Measure	Difficult to Intubate (DTI) Participants n=96 Participants Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
Percentage of Participants With Mallampati Score III and IV Class III	93.8 percentage of participants
Percentage of Participants With Mallampati Score III and IV Class IV	5.2 percentage of participants

SECONDARY outcome

Timeframe: Start of intubation to completion of intubation (up to 15 minutes)

Population: Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.

The mean duration of intubation procedure (in minutes) was defined as the time from intubation start to the completion of the intubation process (from tube introduction to partial pressure of end-tidal carbon dioxide \[PETCO2\]).

Outcome measures

Outcome measures
Measure	Difficult to Intubate (DTI) Participants n=96 Participants Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
Mean Duration of Intubation Procedure (in Minutes)	1.77 minutes Standard Error 0.2

SECONDARY outcome

Timeframe: Start of intubation to completion of intubation (up to 15 minutes)

Population: ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.

The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration.

Outcome measures

Outcome measures
Measure	Difficult to Intubate (DTI) Participants n=97 Participants Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure Hypertension	1.03 percentage of participants
Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure Cough	1.03 percentage of participants

SECONDARY outcome

Timeframe: From start of induction to completion of intubation (up to 30 minutes)

Population: ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.

The percentage of participants who experienced difficulties related to the use of sevoflurane including, but not limited to, vocal cords adduction, coughing, movements, and apnea episodes.

Outcome measures

Outcome measures
Measure	Difficult to Intubate (DTI) Participants n=97 Participants Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane	0 percentage of participants

SECONDARY outcome

Timeframe: Start of intubation to completion of intubation (up to 15 minutes)

Population: Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study's inclusion/exclusion criteria.

Outcome measures

Outcome measures
Measure	Difficult to Intubate (DTI) Participants n=96 Participants Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
Mean Number of Intubation Attempts	1.26 number of attempts Standard Error 0.50

Adverse Events

Difficult to Intubate (DTI) Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Difficult to Intubate (DTI) Participants n=97 participants at risk Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
Respiratory, thoracic and mediastinal disorders Cough	1.0% 1/97 • All AEs were collected from the time of study drug administration to end of intubation procedure (up to 30 minutes); SAEs were also collected from the time that informed consent was obtained until 30 days after last dose of study drug (30 days).
Vascular disorders Hypertension	1.0% 1/97 • All AEs were collected from the time of study drug administration to end of intubation procedure (up to 30 minutes); SAEs were also collected from the time that informed consent was obtained until 30 days after last dose of study drug (30 days).

Additional Information

Global Medical Information

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