A study comparing two drugs fentanyl and dexmedetomidine in decreasing airway and circulatory reflexes during patient coming out of anaesthesia and extubation

Completed

• Conditions: ASA PHYSICAL STATUS 1/2

• Registration Number: CTRI/2015/08/006112
• Lead Sponsor: no

Brief Summary

All patients willreceive a standardized anesthetic protocol. Premedication will be done withoral diazepam 10mg in the night and tab ranitidine 150 mg on the morning of thesurgery. On the OR table after securing IV access inj Midazolam 1mg andinjOndansetron 4 mg are given. Base line hemodynamic parameters will be noted.Analgesia will be provided with morphine 0.1 mg kg1and additionalmorphine based on hemodynamic alterations. Patients will be   induced with 5 mg kg1 injThiopentone. Anesthesia will be maintained with Isoflurane and low flow Nitrousoxide (N2O) & oxygen (600 ml) with total MAC of 1.3. Muscle relaxationwill be achieved with inj. Vecuronium. Fifteen minutes before expected lastsurgical suture, isoflurane is cut off and  equal amount of test solution which is takenby draw of lots  will be given when TOFratio is 30%..Hemodynamic parameters are noted every 2 minutes from the time ofgiving study drug to 15 minutes after extubation.The observers are unaware ofthe study treatment. 5 min after bolus drug, patient is reversed  andgrading ofairway reflexes are done.  Airway reflexes are assessed by a 5 pointscoring system.

•     Grade1-excellent(fullyreversed, breathing well, awake, no response to laryngoscopy & suctioning)

•     Grade2 -good (fully reversed,breathing well ,no coughing on tube, and  awake)

•     Grade3 -satisfactory (fully reversed, no coughing on tube, breathing well and drowsy)

•     Grade 4 -poor (fully reversed, coughing on tube ,breathing well and drowsy )

•     Grade 5 -very poor (coughing on tube with irregular  attempts to breath and not awake)

Changes in heartrate (HR) and blood pressure (BP) will be measured during and after trachealextubation every minute for five minutes. Oro-pharyngeal secretions will beaspirated gently before extubation. Occurrence of cough, laryngospasm, andbronchospasm will be noted.

All patients will receive a standardized anesthetic protocol. Premedication will be done with oral diazepam 10mg in the night and tab ranitidine 150 mg on the morning of the surgery. On the OR table after securing IV access inj Midazolam 1mg and injOndansetron 4 mg are given. Base line hemodynamic parameters will be noted. Analgesia will be provided with morphine 0.1 mg kg1and additional morphine based on hemodynamic alterations. Patients will be   induced with 5 mg kg1 inj Thiopentone. Anesthesia will be maintained with Isoflurane and low flow Nitrous oxide (N2O) & oxygen (600 ml) with total MAC of 1.3. Muscle relaxation will be achieved with inj. Vecuronium. Fifteen minutes before expected last surgical suture, isoflurane is cut off and  equal amount of test solution which is taken by draw of lots  will be given when TOF ratio is 30%..Hemodynamic parameters are noted every 2 minutes from the time of giving study drug to 15 minutes after extubation.The observers are unaware of the study treatment. 5 min after bolus drug, patient is reversed  andgrading ofairway reflexes are done.  Airway reflexes are assessed by a 5 point scoring system.

•      Grade1-excellent(fully reversed, breathing well, awake, no response to laryngoscopy & suctioning)

•      Grade2 - good (fully reversed,breathing well ,no coughing on tube, and  awake)

•      Grade3 - satisfactory (fully reversed, no coughing on tube, breathing well and drowsy)

•      Grade 4 - poor (fully reversed, coughing on tube ,breathing well and drowsy )

•      Grade 5 - very poor (coughing on tube with irregular  attempts to breath and not awake)

Changes in heart rate (HR) and blood pressure (BP) will be measured during and after tracheal extubation every minute for five minutes. Oro-pharyngeal secretions will be aspirated gently before extubation. Occurrence of cough, laryngospasm, and bronchospasm will be noted.

**O2&N2O                                                                     O2**

15min                                                         5 min laterTOF

Isoflurane off          bolus study drug         reversal        assessment

During  extubation smoothness is graded as,

Grade 1- no coughing on endotracheal tube

Grade 2- coughing on the ETT

Grade  3-  vomiting

Grade 4- laryngospasm

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-30
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Willingness •ASA 1 & 2 physical status.

Exclusion Criteria

• Active upper respiratory tract infection 2.
• Who require intraoperative nasogastric tube.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
airway reflexes before extubation	1.airway reflexes are assessed just before extubation | 2.Smoothness is assessed during extubation
smoothness of extubation	1.airway reflexes are assessed just before extubation | 2.Smoothness is assessed during extubation

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure	2 mins interval from study drug administration to 15 mins after extubation

Trial Locations

Locations (1)

Operation theater, Mahatma Gandhi medical college and research institute, PONDICHERRY; 🇮🇳 Pondicherry, PONDICHERRY, India

Operation theater, Mahatma Gandhi medical college and research institute, PONDICHERRY

🇮🇳Pondicherry, PONDICHERRY, India

Dr Rani P

Principal investigator

9443116908

anaesrani@gmail.com