Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant on Sore Throat and Hemodynamics
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|ClinicalTrials.gov Identifier: NCT03031808|
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : March 13, 2019
When a surgical procedure is performed under general anesthesia, the Airways are often secured With an endotracheal tube. Some patients experience sore throat thereafter. Studies have shown a reduction of these side effects when by use of muscle relaxants or a lidocain spray prior to the intubation. At Ostfold Hospital Trust, the investigators use one of the two methods or nothing. These methods will be studied systematically.
Heart rate and blood pressure rise during the intubation procedure. The investigators will also study the differences between the groups.
|Condition or disease||Intervention/treatment||Phase|
|Intubation Complication||Drug: Lidocaine spray (2%) Drug: Muscle Relaxant (Rocuronium) Other: No Muscle relaxant, no Lidocaine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Comparison of Two Induction Regimens Using Topical Lidocaine or Muscle Relaxant; Impact on Postoperative Sore Throat and Haemodynamics|
|Actual Study Start Date :||October 31, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Endotracheal lidocaine spray prior to intubation
Drug: Lidocaine spray (2%)
Spraying trachea from 2 cm above the vocal cords and 5 cm down with a straw with multiple side holes
Other Name: Xylocain 2% Astra Zeneca
Muscle relaxant prior to intubation
Drug: Muscle Relaxant (Rocuronium)
After induction of anesthesia, the participants are given 0,6 mg/kg bodyweight intravenously.
Other Name: Esmeron MSD
No Muscle relaxant, no Lidocaine
'No Muscle relaxant, no Lidocaine Control group
Other: No Muscle relaxant, no Lidocaine
This group get general anesthesia without Rocuronium or Lidocaine
Other Name: Control group
- Sore Throat postoperative. Assessment of complaints and changes in complaints [ Time Frame: 2 h and 24 h after extubation ]Postoperative sore throat, described 2 h and 24 h after extubation. If the patient has sore throat or is hoarse, the complaint is assessed on a VAS (Visual Analogue Scale) 1 - 10.
- Intubation conditions directly after induction of anesthesia [ Time Frame: 90 sec. after established general anesthesia ]Describes the intubation conditions: Jaw relaxation, resistance to laryngoscopy blade, the position and movement of vocal cords, the movement of limbs and coughing. Each variable rates as excellent, good or poor. Intubation conditions are many variables described once and should not be divided into several outcomes.
- Hemodynamic parameters, change in HR (Heart Rate) is being assessed [ Time Frame: Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.) ]Describes changes in HR (Heart Rate)
- Hemodynamic parameters, change in BP (blood pressure) is being assessed [ Time Frame: Prior to induction, then every second minute the next 15 minutes, thereafter every 15 minute until end of surgery (max. 2 h.) ]Describes changes in BP(Blood Pressure)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031808
|Contact: Jan Sverre Vamnes, MD, Ph.D||+47 913 05 firstname.lastname@example.org|
|Contact: Knut Inge Solbakk, MD||+47 909 33 email@example.com|
|Study Chair:||Jan Sverre Vamnes, MD, Ph.D.||Senior consultant|