AnesthesiaPhase 4NCT03833947
Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in General Anaesthesia
A Phase 4 study testing lignocaine+bicarbonate and lignocaine+dexamethasone in people with Anesthesia and Anesthesia; Adverse Effect, run by Aligarh Muslim University at 1 site in India.
Trial summary
This study is designed to evaluate and compare the effect on hemodynamics, extubation response and patients satisfaction score in patients with ETT cuff filled with either mixture of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Anesthesia; Adverse Effect, Anesthesia Intubation Complication
- What is being tested?
- lignocaine+bicarbonate and lignocaine+dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 15 Mar 2019to 30 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class I \& II.
- Elective surgery
- General anesthesia of duration >120 minutes.
Who cannot join
- Patients with ASA III \& IV.
- Known Cardiovascular morbidities.
- Pregnancy.
- Allergic to used drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparision of Addition of Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in Terms of Extubation Characteristics and Patient Satisfaction Undergoing General Anaesthesia
This study is designed to evaluate and compare the effect on hemodynamics, extubation response and patients satisfaction score in patients with ETT cuff filled with either mixture of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.
Read the detailed description
Objective Recently multiple studies have shown better outcomes with usage of dexamethasone or alkalinized lignocaine instead of air for filling endotracheal tube (ETT) cuff. So this study is designed to evaluate and compare the effect on hemodynamics, extubation response and patients satisfaction score in patients with ETT cuff filled with either mixture of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.
Design and setting:
This is a prospective single blind, randomized controlled study at the department of anesthesiology, JNMCH, AMU, Aligarh.
Materials and methods:
Investigators plan to include 100 patients of age group within 18-60 years with American Society of Anesthesiologists (ASA) class I \& II, posted for elective surgery of duration >120 minutes, performed under general anesthesia; administered as per institutional protocols. Patients with ASA III \& IV, cardiovascular morbidities, known drug allergy, pregnancy will be excluded from the study. Patients will be divided into two groups randomly according to chit-in-box method, viz Group A \& Group D with fifty patients in each group. Patient group allocation, preparation of drug mixture for endotracheal cuff filling as per group assigned and analysis of observed data will be done by a separate anesthetist not involved in the perioperative management of the patient. In patients belonging to Group (A), ETT cuff will be filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in the proportions of 0.5: 9.5 ml while in Group D the ETT cuff will be filled with mixture of dexamethasone with 2% lignocaine in the proportions of 0.5: 9.5 ml . The cuff of the ETT will be slowly inflated until no leak is heard at all during the peak airway pressure of the ventilator cycle while auscultating the trachea . Volume of drug mixture in the cuff will be noted at start and end of surgery. Total duration of anesthesia will be noted.
Hemodynamic stability at the time of extubation will be meausred in terms of changes in rate pressure product (RPP) which will denote the product of heart rate and systolic blood pressure. RPP values recorded immediately after stoppage of the anesthetic agents at the end of surgery will be compared to the values measured just after the extubation of trachea. Patient's satisfaction from anesthesia given will be recorded, based on VAS. The presence of coughing and bucking will also be noted. Incidence of postoperative sore throat and cough will be recorded at 1 hour and 24 hours post extubation.
The results will be presented in number, percentage, mean, and standard deviation as appropriate. Appropriate statistical tests will be applied and P value less than 0.05 will be considered as statistically significant.
- Being tested
- lignocaine+bicarbonate, lignocaine+dexamethasone
- Keywords
- Intracuff Dexamethasone, Intracuff Alkalinized lignocaine, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lignocaine+bicarbonateDrug
ETT cuff was filled with mixture of 2% lignocaine with bicarbonate
lignocaine+dexamethasoneDrug
ETT cuff was filled with mixture of 2% lignocaine with dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| lignocaine with bicarbonate | Experimental | Endotracheal tube cuff was filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in a ratio of 0.5:9.5 ml Receives: Drug: lignocaine+bicarbonate |
| lignocaine with dexamethasone | Active comparator | Endotracheal tube cuff was filled with mixture of dexamethasone with 2% lignocaine in a ratio of 0.5:9.5 ml Receives: Drug: lignocaine+dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoothness of extubation
Grade 1= coughing, bucking, tube biting, agitatation present. Grade 2= mild bucking/coughing. Grade 3= completely comfortable, tolerating tube in situ, no coughing/bucking/agitation.
Measured: time from adequate reversal of anaesthesia & muscle paralysis (head holding >5sec, eye opening on command, train of four ratio >0.9) till removal of endotracheal tube.
patient satisfaction score
rated on visual analog scale varying 0 to 10; where 0 is worst experience and 10 is best. completely
Measured: post operative 1 hour
Secondary outcomes (3)
Haemodynamic stability at the time of extubation.
Rate pressure product (RPP); [RPP=Product of systolic blood pressure(mmHg) and heart rate (beats per min)] measured after stopping the anaesthetic agents at the end of surgery will be taken as baseline and then compared to values measured immediately after the removal of endotracheal tube.
Measured: values of product of systolic blood pressure and heart rate will be compared after stopping the anesthetic agents and immediately after the extubation
amount of drug diffused through endotracheal tube cuff
Volume of drug mixture in the cuff was noted at start and end of surgery.
Measured: from start till end of surgery.
incidence of post operative cough and sore throat
incidence of post operative cough and sore throat
Measured: after 1 and 24 hour post extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start15 Mar 2019
- Primary completion30 Oct 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aligarh Muslim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MUAZZAM HASAN, Aligarh Muslim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833947
- Sponsor's protocol ID
- AligarhMUmzm
- Status last verified
- Jan 2020
- First submitted
- 24 Jan 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of Addition of Dexamethasone vs Bicarbonate to Intracuff Lignocaine 2% in Terms of Extubation Characteristics and Patient Satisfaction Undergoing General Anaesthesia
- ClinicalTrials.gov ID
- NCT03833947
- Acronym / sponsor ID
- AligarhMUmzm
- Keywords
- Intracuff Dexamethasone, Intracuff Alkalinized lignocaine, General anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aligarh Muslim UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate and compare the effect on hemodynamics, extubation response and patients satisfaction score in patients with ETT cuff filled with either mixture of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.
Detailed description
Objective Recently multiple studies have shown better outcomes with usage of dexamethasone or alkalinized lignocaine instead of air for filling endotracheal tube (ETT) cuff. So this study is designed to evaluate and compare the effect on hemodynamics, extubation response and patients satisfaction score in patients with ETT cuff filled with either mixture of lignocaine with sodium bicarbonate or with a mixture of lignocaine with dexamethasone.
Design and setting:
This is a prospective single blind, randomized controlled study at the department of anesthesiology, JNMCH, AMU, Aligarh.
Materials and methods:
Investigators plan to include 100 patients of age group within 18-60 years with American Society of Anesthesiologists (ASA) class I \& II, posted for elective surgery of duration >120 minutes, performed under general anesthesia; administered as per institutional protocols. Patients with ASA III \& IV, cardiovascular morbidities, known drug allergy, pregnancy will be excluded from the study. Patients will be divided into two groups randomly according to chit-in-box method, viz Group A \& Group D with fifty patients in each group. Patient group allocation, preparation of drug mixture for endotracheal cuff filling as per group assigned and analysis of observed data will be done by a separate anesthetist not involved in the perioperative management of the patient. In patients belonging to Group (A), ETT cuff will be filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in the proportions of 0.5: 9.5 ml while in Group D the ETT cuff will be filled with mixture of dexamethasone with 2% lignocaine in the proportions of 0.5: 9.5 ml . The cuff of the ETT will be slowly inflated until no leak is heard at all during the peak airway pressure of the ventilator cycle while auscultating the trachea . Volume of drug mixture in the cuff will be noted at start and end of surgery. Total duration of anesthesia will be noted.
Hemodynamic stability at the time of extubation will be meausred in terms of changes in rate pressure product (RPP) which will denote the product of heart rate and systolic blood pressure. RPP values recorded immediately after stoppage of the anesthetic agents at the end of surgery will be compared to the values measured just after the extubation of trachea. Patient's satisfaction from anesthesia given will be recorded, based on VAS. The presence of coughing and bucking will also be noted. Incidence of postoperative sore throat and cough will be recorded at 1 hour and 24 hours post extubation.
The results will be presented in number, percentage, mean, and standard deviation as appropriate. Appropriate statistical tests will be applied and P value less than 0.05 will be considered as statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lignocaine with bicarbonate | Experimental | Drug: lignocaine+bicarbonateEndotracheal tube cuff was filled with mixture of 7.5% sodium bicarbonate with 2% lignocaine in a ratio of 0.5:9.5 ml |
| lignocaine with dexamethasone | Active comparator | Drug: lignocaine+dexamethasoneEndotracheal tube cuff was filled with mixture of dexamethasone with 2% lignocaine in a ratio of 0.5:9.5 ml |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) class I \& II.
- Elective surgery
- General anesthesia of duration >120 minutes.
Key exclusion criteria (4 listed)
- Patients with ASA III \& IV.
- Known Cardiovascular morbidities.
- Pregnancy.
- Allergic to used drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lignocaine+bicarbonateETT cuff was filled with mixture of 2% lignocaine with bicarbonate | Drug | lignocaine with bicarbonate |
| lignocaine+dexamethasoneETT cuff was filled with mixture of 2% lignocaine with dexamethasone | Drug | lignocaine with dexamethasone |
Primary outcome
smoothness of extubation
Time frame: time from adequate reversal of anaesthesia & muscle paralysis (head holding >5sec, eye opening on command, train of four ratio >0.9) till removal of endotracheal tube.
Grade 1= coughing, bucking, tube biting, agitatation present. Grade 2= mild bucking/coughing. Grade 3= completely comfortable, tolerating tube in situ, no coughing/bucking/agitation.
patient satisfaction score
Time frame: post operative 1 hour
rated on visual analog scale varying 0 to 10; where 0 is worst experience and 10 is best. completely
3 secondary outcomes
Haemodynamic stability at the time of extubation.
Time frame: values of product of systolic blood pressure and heart rate will be compared after stopping the anesthetic agents and immediately after the extubation
amount of drug diffused through endotracheal tube cuff
Time frame: from start till end of surgery.
incidence of post operative cough and sore throat
Time frame: after 1 and 24 hour post extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lignocaine+bicarbonate and lignocaine+dexamethasone in people with Anesthesia and Anesthesia; Adverse Effect, run by Aligarh Muslim University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smoothness of extubation (time frame: time from adequate reversal of anaesthesia & muscle paralysis (head holding >5sec, eye opening on command, train of four ratio >0.9) till removal of endotracheal tube.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.