Laparoscopic CholecystectomyNCT04138472
Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy
A study testing dexmedetomidine, fentanyl and lidocaine in people with Laparoscopic Cholecystectomy, run by Sana Urooj at 2 sites in Pakistan.
Trial summary
Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- dexmedetomidine, fentanyl and lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPakistan
- Study dates
- 30 Oct 2019to 29 Feb 2020
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA-I and ll patients
- Male and female patient of age 20-70 years.
- Undergoing Elective surgery
- Intubation by skilled anesthetist of at least 2 years' experience
- Intubation not more than 45 seconds
Who cannot join
- Patients with uncontrolled DM, HTN, IHD, endocrine or autonomic dysfunction
- Pregnant and lactating females
- Short thick neck with anticipated difficult intubation
- Any sort of obstructive restrictive or reactive airway disease
- Patient allergic to any of the study medications.
- Obese patients, Narcotic addicts
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
DUHS, Civil hospital Karachi (CHK)
Karachi, Sindh, 75520
0333351560, dr.sanaurooj@yahoo.com
Sana Urooj, FCPS
- Recruiting
DUHS, Civil hospital Karachi (CHK)
Karachi, Sindh, 75520
About this study
Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy
Read the detailed description
Direct laryngoscopy and intubation are painful stimulus that activates sympathoadrenal discharge which results in intense cardiovascular reflex i.e. tachycardia and hypertension. In this study we will compare effects of intravenous dexmedetomidine, fentanyl and lidocaine for attenuation of these reflexes in patient undergoing laproscopic cholecystectomy. how these agents will effect hemodynamic response during pneumoperitoneum. Tertiary objective will be to observe sedation, perioperative complications and recovery in these patients.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- dexmedetomidine, fentanyl, lidocaine
- Keywords
- Dexmedetomidine, Fentanyl, Lignocaine, Laryngoscopy, Hemodynamic Response, Laparoscopic Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
intravenous dexmedetomidine 0.06mg/kg in 100ml normal saline 0.9% over 10minutes.
fentanylDrug
intravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room.
lidocaineDrug
intravenous lidocaine 1.5mg/kg in 100ml saline over 10 minutes in induction room.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Group A patients receive intravenous dexmedetomidine 0.06mg/kg in 100ml normal saline 0.9% over 10minutes. Receives: Drug: dexmedetomidine |
| Fentanyl | Experimental | Group B receives intravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room. Receives: Drug: fentanyl |
| Lidocaine | Experimental | Group C patients receives intravenous lidocaine 1.5mg/kg in 100ml saline over 10 minutes in induction room. Receives: Drug: lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
hermodynamic response (Top number will be assessed of blood pressure)
Measured: at induction
Diastolic blood pressure
hermodynamic response (bottom number will be assessed of blood pressure)
Measured: at induction
mean atrial pressure
Hemodynamic responses (average blood pressure in an individual during a single cardiac cycle)
Measured: at induction
Heart rate
Hemodynamic responses (average heart rate beats a minute)
Measured: at induction
Oxygen saturation (SpO2)
Hemodynamic responses) (arterial oxy-hemoglobin saturation is measured non-invasively by a finger pulse oximeter or handheld pulse oximeter,
Measured: at induction
Secondary outcomes (3)
Sedation assessment
Ramsey score use for sedation, it consist of 1-6 where 6 indicates worst(no response) and 6 indicates good response
Measured: at 10 minutes post operative
Recovery assessment
Aldret score use for recovery assessment, it consist of 0-10 point where 0 indicates worst(no response) and 10 indicates good response
Measured: at 10 minutes post operatively
Complications
Cough, Laryngospasm, Bradycardia, Regugitation, PONV, Hypertention, Hypotension
Measured: 1 week Post-operative(Operation -discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start30 Oct 2019
- Primary completion29 Feb 2020 (estimated)
- Study completion29 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana Urooj
- Sponsor type
- University, hospital or other
- Collaborators
- Dow University of Health Sciences
- Responsible party
- Sponsor-investigator, Sana Urooj, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138472
- Sponsor's protocol ID
- 3
- Status last verified
- Feb 2020
- First submitted
- 14 Oct 2019
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04138472
- Acronym / sponsor ID
- 3
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- Dexmedetomidine, Fentanyl, Lignocaine, Laryngoscopy, Hemodynamic Response, Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sana UroojUniversity, hospital or other
- Collaborators
- Dow University of Health Sciences
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 29 Feb 2020 (estimated)
- Study completion
- 29 Feb 2020 (estimated)
- First posted
- 24 Oct 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.
Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy
Detailed description
Direct laryngoscopy and intubation are painful stimulus that activates sympathoadrenal discharge which results in intense cardiovascular reflex i.e. tachycardia and hypertension. In this study we will compare effects of intravenous dexmedetomidine, fentanyl and lidocaine for attenuation of these reflexes in patient undergoing laproscopic cholecystectomy. how these agents will effect hemodynamic response during pneumoperitoneum. Tertiary objective will be to observe sedation, perioperative complications and recovery in these patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: dexmedetomidineGroup A patients receive intravenous dexmedetomidine 0.06mg/kg in 100ml normal saline 0.9% over 10minutes. |
| Fentanyl | Experimental | Drug: fentanylGroup B receives intravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room. |
| Lidocaine | Experimental | Drug: lidocaineGroup C patients receives intravenous lidocaine 1.5mg/kg in 100ml saline over 10 minutes in induction room. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA-I and ll patients
- Male and female patient of age 20-70 years.
- Undergoing Elective surgery
- Intubation by skilled anesthetist of at least 2 years' experience
- Intubation not more than 45 seconds
Key exclusion criteria (6 listed)
- Patients with uncontrolled DM, HTN, IHD, endocrine or autonomic dysfunction
- Pregnant and lactating females
- Short thick neck with anticipated difficult intubation
- Any sort of obstructive restrictive or reactive airway disease
- Patient allergic to any of the study medications.
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 |
|---|---|---|
| dexmedetomidineintravenous dexmedetomidine 0.06mg/kg in 100ml normal saline 0.9% over 10minutes. | Drug | Dexmedetomidine |
| fentanylintravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room. | Drug | Fentanyl |
| lidocaineintravenous lidocaine 1.5mg/kg in 100ml saline over 10 minutes in induction room. | Drug | Lidocaine |
Primary outcome
systolic blood pressure
Time frame: at induction
hermodynamic response (Top number will be assessed of blood pressure)
Diastolic blood pressure
Time frame: at induction
hermodynamic response (bottom number will be assessed of blood pressure)
mean atrial pressure
Time frame: at induction
Hemodynamic responses (average blood pressure in an individual during a single cardiac cycle)
Heart rate
Time frame: at induction
Hemodynamic responses (average heart rate beats a minute)
Oxygen saturation (SpO2)
Time frame: at induction
Hemodynamic responses) (arterial oxy-hemoglobin saturation is measured non-invasively by a finger pulse oximeter or handheld pulse oximeter,
3 secondary outcomes
Sedation assessment
Time frame: at 10 minutes post operative
Recovery assessment
Time frame: at 10 minutes post operatively
Complications
Time frame: 1 week Post-operative(Operation -discharge)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexmedetomidine, fentanyl and lidocaine in people with Laparoscopic Cholecystectomy, run by Sana Urooj at 2 sites in Pakistan.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sana Urooj, FCPS (+923333515690, dr.sanaurooj@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure (time frame: at induction). The study lists 5 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 7 Feb 2020.