Optimal Remifentanil Ce for Preventing Severe Cough and Hyperdynamic Response During Tracheal Extubation

NCT ID: NCT03132519

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-02-29

Brief Summary

Pain, cough, hypertension and tachycardia are frequent events during extubation due to a secondary stimulation of mechanoreceptors located in the airway. The mechanical effect of the endotracheal tube activates autonomic reflexes, a situation that could potentially impair the clinical condition of patients. Previous studies have used remifentanil during emergence and extubation showing good results to control this reflex response. However, it is unknown so far, the optimal effect site concentration (Ce) of remifentanil to allow a better control of these events with a low incidence of adverse effects after have received inhaled anesthesia plus remifentanil for anesthetic maintenance. This study will determine the Ce of remifentanil associated with a lower proportion of cough and hyperdynamic circulatory response during extubation for emergency after exposure to sevoflurane or desflurane.

Detailed Description

Single-center, randomized, double-blind protocol. The investigators aim to include 368 patients under balanced anesthesia with sevoflurane or desflurane to be randomly allocated into 6 different remifentanil Ce groups [77 individuals in each of interventional groups (2.0 vs. 2.5 ng/ml) and 30 in each of the control groups (1.0 ng/ml) administrated by a target-controlled infusion (TCI) system during emergence and tracheal extubation .

Once informed consent is obtained and inclusion/exclusion criteria are met, subjects will be randomized before starting of the surgical procedure. This information will remain blinded to the attendant anesthesiologist and the independent evaluator during the process of extubation, except for type of inhaled anesthetic for maintenance .

The intervention will start when the anesthesiologist decide to suspend the sevorane or desflurane dial. At this moment, the fresh flow gas of the anesthesia machine will be adjusted to 7-8 liters per minute and the infusion of remifentanil will be set up to establish a Ce of 2.0 ng/ml or 2.5 ng/ml. All patients will be extubated only when all of these three parameters exist: response to name by eyes opening, response to orders of breathing and mouth opening.

The evaluation and outcomes measurement will include: Presence and intensity of cough and changes in heart rate and blood pressure during eyes opening in response to calling by name, tracheal extubation and 2.5 min after, time to get to be extubated after inhaled anesthetic discontinuation, episodes of hypoxemia and sedation state during the first 25 minutes after extubation, requirements of rescue analgesia and postoperative nausea and vomit during this period.

Close monitoring of patients will take place and data will be collected during the preoperative, intraoperative and postoperative stages until discharge from the post anesthesia care unit. Lost to follow and adverse events will be assessed. An interim committee will evaluate partial results of the study when it reaches 25 and 50% of recruitment, so the investigators can continue building thereof according to analysis obtained.

Statistical analysis will be performed by a independent statistician based on "intention to treat" principle. In addition, excluded data and its reasons for exclusion will be evaluated. For the descriptive exploratory analysis, continuous variables will be presented as means (standard deviation) or medians (interquartile ranges). The degree of dispersion, shape and position as the fulfillment of normality will be analyzed using the t of Student or Mann-Whitney tests as appropriate. Categorical variables will be presented as proportions and compared using the chi-square or Fisher 's exact tests as appropriate. Time-varying measures analysis of variance for repeated measures will be used to make comparisons between groups.

Conditions

Cough; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sevo-2.0

This group will maintain remifentanil infusion by TCI to 2 ng/ml during emergence and extubation after have received sevoflurane during procedure.

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

To maintain remifentanil Ce at 1.0 (control) vs. 2.0 vs. 2.5 ng/ml by a TCI system during anesthesia emergence until tracheal extubation

Sevo-2.5

This group will maintain the remifentanil infusion by TCI to 2.5 ng/ml during emergence and tracheal extubation after have received sevoflurane during surgical procedure.

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

To maintain remifentanil Ce at 1.0 (control) vs. 2.0 vs. 2.5 ng/ml by a TCI system during anesthesia emergence until tracheal extubation

Des-2.0

This group will maintain the remifentanil infusion by TCI to 2.0 ng/ml during emergence and tracheal extubation after have received desflurane during surgical procedure.

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

To maintain remifentanil Ce at 1.0 (control) vs. 2.0 vs. 2.5 ng/ml by a TCI system during anesthesia emergence until tracheal extubation

Des-2.5

This group will maintain the remifentanil infusion by TCI to 2.5 ng/ml during emergence and tracheal extubation after have received desflurane during surgical procedure.

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

To maintain remifentanil Ce at 1.0 (control) vs. 2.0 vs. 2.5 ng/ml by a TCI system during anesthesia emergence until tracheal extubation

Sevo-Control

This group will maintain the remifentanil infusion by TCI to 1.0 ng/ml during emergence and tracheal extubation after have received sevoflurane during surgical procedure.

Group Type: ACTIVE_COMPARATOR

Remifentanil

Intervention Type: DRUG

To maintain remifentanil Ce at 1.0 (control) vs. 2.0 vs. 2.5 ng/ml by a TCI system during anesthesia emergence until tracheal extubation

Des-Control

This group will maintain the remifentanil infusion by TCI to 1.0 ng/ml during emergence and tracheal extubation after have received desflurane during surgical procedure.

Group Type: ACTIVE_COMPARATOR

Remifentanil

Intervention Type: DRUG

To maintain remifentanil Ce at 1.0 (control) vs. 2.0 vs. 2.5 ng/ml by a TCI system during anesthesia emergence until tracheal extubation

Interventions

Remifentanil

To maintain remifentanil Ce at 1.0 (control) vs. 2.0 vs. 2.5 ng/ml by a TCI system during anesthesia emergence until tracheal extubation

Intervention Type: DRUG

Other Intervention Names

Ultiva

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesia status I and II
• Age between 18 to 60 years.
• Elective surgery.

Exclusion Criteria

• Uncontrolled hypertension. (SBP> 180 mmHg) at pre anesthesia area.
• Active or uncontrolled pulmonary disease.
• Signs or history of difficult airway.
• Recent respiratory infection.
• Train-of-four (TOF) index <90% at the end of surgery.
• Patients who have received some form of pre oral medication.
• Body mass Index above 30 kg/m2.
• Concomitant use of epidural catheter.
• Urgent surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacion Clinica Valle del Lili

OTHER

Sponsor Role: lead

Responsible Party

Fredy Ariza

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fredy G Ariza, MD., MSc.

Role: PRINCIPAL_INVESTIGATOR

Fundacion Clinica Valle del Lili

Ivan F Quintero, MD

Role: STUDY_CHAIR

Fundacion Clinica Valle del Lili

Locations

Fundacion Valle del Lili

Cali, Valle del Cauca Department, Colombia

Countries

Colombia

Other Identifiers

REX

Identifier Type: -

Identifier Source: org_study_id