CholecystectomyNCT04089592
Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.
A study testing Dexmedetomidine and Fentanyl in people with Cholecystectomy and Elective Surgery, run by Dow University of Health Sciences at 2 sites in Pakistan.
Trial summary
Compare effects of intravenous dexmedetomidine and fentanyl in attenuation of intubation response in a patient undergoing laparoscopic cholecystectomy. Compare the effects of intravenous dexmedetomidine and fentanyl in sedation, perioperative complications, and recovery in these patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cholecystectomy, Elective Surgery
- What is being tested?
- Dexmedetomidine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Jan 2019to 15 Jul 2019
- 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 70 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 laparoscopic cholecystectomy.
Who cannot join
- Pregnant and lactating females
- Short thick neck with anticipated difficult intubation.
- Obese patients.
- Narcotic addicts.
- Full stomach patient or with higher chances of aspiration.
- Patient allergic to any of the study medications.
- Patients high risk to develop serotonin syndrome. (patient taking an antidepressant and other psychomotor medications.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Civil Hospital Karachi
Karachi, Sindh, 75520
DUHS, Civil hospital Karachi (CHK)
Karachi, Sindh, 75520
About this study
Compare effects of intravenous dexmedetomidine and fentanyl in attenuation of intubation response in a patient undergoing laparoscopic cholecystectomy.
Compare the effects of intravenous dexmedetomidine and fentanyl in sedation, perioperative complications, and recovery in these patients.
Read more
Dexmedetomidine is comparatively a newer drug in countries like Pakistan. There is no research work available at the national level and scarcity of data at an international level with inconclusive outcomes. Our participation in the form of this research will add to scientific literature and step up ahead at the international level.
Fentanyl citrate is a narcotic analgesic interacting predominantly with the opioid μ receptor and exerting its principal pharmacological effect on CNS. Its primary action of therapeutic value is analgesia and sedation. It is extensively used for anesthetic and analgesic most often in operating room and ICU.
Read the detailed description
This is double-blind, a single centered randomized clinical trial which is based on assessing the hemodynamic stability provided by our study drugs during laryngoscopy and intubation in a patient undergoing laparoscopic cholecystectomy. In addition to that this study will assess the perioperative complication and postoperative recovery in these patients. Laparoscopy has now become the standard technique of choice for cholecystectomy which results in pathophysiological changes characterized by an increase in arterial pressure and heart rate (HR). Many types of research have been done in an attempt to minimize adverse effects by adding adjuvants to the conventional method of general anesthesia. Our research is also based on this aim. The objective of this study to determine the hemodynamic stability during laryngoscopy and intubation, peri-operative complication and post-operative recovery. The patients will be divided into two groups randomly and will be given the desired drugs via intravenous line by on floor consultant anesthetist who will be blinded to the drug. The study subjects' hemodynamics will be observed until 10 minutes of intubation. Any perioperative complication will be noted. The subjects will also be followed postoperatively in recovery to check there sedation score and recovery (Aldrete score) will be noted after 10 minutes after the patient shifted to recovery.
- Conditions
- Cholecystectomy, Elective Surgery
- Being tested
- Dexmedetomidine, Fentanyl
- Keywords
- Laparoscopic Cholecystectomy, Dexmedetomidine, Fentanyl, Hemodynamics response, Direct laryngoscopy, Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Fentanyl
intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%
FentanylDrug
Also called Dexmedetomidine
intravenous fentanyl at 2mcg/kg in 100ml saline
| Study group | Role | What they receive |
|---|---|---|
| Dex Group | Experimental | intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9% Receives: Drug: Dexmedetomidine |
| Fent Group | Experimental | intravenous fentanyl at 2mcg/kg in 100ml saline Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at Baseline
Systolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: 0 minute
Systolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: 1 minute
Systolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: 3 minute
Systolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: 5 minute
Systolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: 10 minute
Diastolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at Baseline
Diastolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: 0 minute
Diastolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 1 minute
Diastolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 3 minutes
Diastolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 5 minutes
Diastolic blood pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 10 minutes
Heart rate
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at Baseline
Heart rate
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 0 minute
Heart rate
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 1 minute
Heart rate
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 3 minutes
Heart rate
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: 5 minutes
Heart rate
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 10 minutes
Mean atrial pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at Baseline
Mean atrial pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 0 minute
Mean atrial pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 1 minute
Mean atrial pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 3 minute
Mean atrial pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 5 minute
Mean atrial pressure
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 10 minute
SpO (oxygen saturation)
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at Baseline
SpO (oxygen saturation)
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 0 minute
SpO (oxygen saturation)
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 1 minute
SpO (oxygen saturation)
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 3 minute
SpO (oxygen saturation)
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 5 minute
SpO (oxygen saturation)
Hemodynamic response(induction) will be assessed on different point in time during procedure
Measured: at 10 minute
Secondary outcomes (11)
Ramsey score
Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response
Measured: at arrival
Ramsey score
Sedation scale with minimum score 1 indicate good response and maximum score 6 worst response
Measured: at 10 minutes
Aldrete score
Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery
Measured: at arrival
Aldrete score
Post anesthesia Recovery assessment scale with minimum score 0 indicate worst response and maximum score 10 indicate excellent recovery
Measured: at 10 min
Complications
Post operative complication
Measured: Will be assessed within Hospital stay at follow for 1 week
Laryngospasm
Post operative complication
Measured: Will be assessed within Hospital stay at follow for 1 week
Bradycardia
Post operative complication
Measured: Will be assessed within Hospital stay at follow for 1 week
Regurgitation
Post operative complication
Measured: Will be assessed within Hospital stay at follow for 1 week
Post operative vomiting and nausea
Post operative complication
Measured: Will be assessed within Hospital stay at follow for 1 week
Hypertension
Post operative complication
Measured: Will be assessed within Hospital stay at follow for 1 week
Hypotension
Post operative complication
Measured: Will be assessed within Hospital stay at follow for 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start15 Jan 2019
- Primary completion15 May 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT, Double-blind, Randomized control trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Urooj, Dow University of Health Sciences
- Investigators
- Sana Urooj, FCPS, Principal investigator, Dr. Ruth K.M. Pfau Civil Hospital, Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089592
- Sponsor's protocol ID
- SUrooj
- Status last verified
- Sep 2019
- First submitted
- 22 Aug 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaswani JP, Debata D, Vyas V, Pattil S. Comparative Study of the Effect of Dexmedetomidine Vs. Fentanyl on Haemodynamic Response in Patients Undergoing Elective Laparoscopic Surgery. J Clin Diagn Res. 2017 Sep;11(9):UC04-UC08. doi: 10.7860/JCDR/2017/27020.10578. Epub 2017 Sep 1.
PubMed 29207810
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.
- ClinicalTrials.gov ID
- NCT04089592
- Acronym / sponsor ID
- SUrooj
- Conditions
- Cholecystectomy, Elective Surgery
- Keywords
- Laparoscopic Cholecystectomy, Dexmedetomidine, Fentanyl, Hemodynamics response, Direct laryngoscopy, Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 13 Sep 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.
Compare effects of intravenous dexmedetomidine and fentanyl in attenuation of intubation response in a patient undergoing laparoscopic cholecystectomy.
Compare the effects of intravenous dexmedetomidine and fentanyl in sedation, perioperative complications, and recovery in these patients.
Dexmedetomidine is comparatively a newer drug in countries like Pakistan. There is no research work available at the national level and scarcity of data at an international level with inconclusive outcomes. Our participation in the form of this research will add to scientific literature and step up ahead at the international level.
Fentanyl citrate is a narcotic analgesic interacting predominantly with the opioid μ receptor and exerting its principal pharmacological effect on CNS. Its primary action of therapeutic value is analgesia and sedation. It is extensively used for anesthetic and analgesic most often in operating room and ICU.
Detailed description
This is double-blind, a single centered randomized clinical trial which is based on assessing the hemodynamic stability provided by our study drugs during laryngoscopy and intubation in a patient undergoing laparoscopic cholecystectomy. In addition to that this study will assess the perioperative complication and postoperative recovery in these patients. Laparoscopy has now become the standard technique of choice for cholecystectomy which results in pathophysiological changes characterized by an increase in arterial pressure and heart rate (HR). Many types of research have been done in an attempt to minimize adverse effects by adding adjuvants to the conventional method of general anesthesia. Our research is also based on this aim. The objective of this study to determine the hemodynamic stability during laryngoscopy and intubation, peri-operative complication and post-operative recovery. The patients will be divided into two groups randomly and will be given the desired drugs via intravenous line by on floor consultant anesthetist who will be blinded to the drug. The study subjects' hemodynamics will be observed until 10 minutes of intubation. Any perioperative complication will be noted. The subjects will also be followed postoperatively in recovery to check there sedation score and recovery (Aldrete score) will be noted after 10 minutes after the patient shifted to recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- RCT, Double-blind, Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Dex Group | Experimental | Drug: Dexmedetomidineintravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9% |
| Fent Group | Experimental | Drug: Fentanylintravenous fentanyl at 2mcg/kg in 100ml saline |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA-I and ll patients
- Male and female patient of age 20-70 years.
- Undergoing Elective laparoscopic cholecystectomy.
Key exclusion criteria (7 listed)
- Pregnant and lactating females
- Short thick neck with anticipated difficult intubation.
- Obese patients.
- Narcotic addicts.
- Full stomach patient or with higher chances of aspiration.
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 |
|---|---|---|
| DexmedetomidineAlso: Fentanylintravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9% | Drug | Dex Group |
| FentanylAlso: Dexmedetomidineintravenous fentanyl at 2mcg/kg in 100ml saline | Drug | Fent Group |
Primary outcome
Systolic blood pressure
Time frame: at Baseline
Hemodynamic response(induction) will be assessed on different point in time during procedure
Systolic blood pressure
Time frame: 0 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Systolic blood pressure
Time frame: 1 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Systolic blood pressure
Time frame: 3 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Systolic blood pressure
Time frame: 5 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Systolic blood pressure
Time frame: 10 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Diastolic blood pressure
Time frame: at Baseline
Hemodynamic response(induction) will be assessed on different point in time during procedure
Diastolic blood pressure
Time frame: 0 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Diastolic blood pressure
Time frame: at 1 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Diastolic blood pressure
Time frame: at 3 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
Diastolic blood pressure
Time frame: at 5 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
Diastolic blood pressure
Time frame: at 10 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
Heart rate
Time frame: at Baseline
Hemodynamic response(induction) will be assessed on different point in time during procedure
Heart rate
Time frame: at 0 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Heart rate
Time frame: at 1 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Heart rate
Time frame: at 3 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
Heart rate
Time frame: 5 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
Heart rate
Time frame: at 10 minutes
Hemodynamic response(induction) will be assessed on different point in time during procedure
Mean atrial pressure
Time frame: at Baseline
Hemodynamic response(induction) will be assessed on different point in time during procedure
Mean atrial pressure
Time frame: at 0 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Mean atrial pressure
Time frame: at 1 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Mean atrial pressure
Time frame: at 3 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Mean atrial pressure
Time frame: at 5 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
Mean atrial pressure
Time frame: at 10 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
SpO (oxygen saturation)
Time frame: at Baseline
Hemodynamic response(induction) will be assessed on different point in time during procedure
SpO (oxygen saturation)
Time frame: at 0 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
SpO (oxygen saturation)
Time frame: at 1 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
SpO (oxygen saturation)
Time frame: at 3 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
SpO (oxygen saturation)
Time frame: at 5 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
SpO (oxygen saturation)
Time frame: at 10 minute
Hemodynamic response(induction) will be assessed on different point in time during procedure
11 secondary outcomes
Ramsey score
Time frame: at arrival
Ramsey score
Time frame: at 10 minutes
Aldrete score
Time frame: at arrival
Aldrete score
Time frame: at 10 min
Complications
Time frame: Will be assessed within Hospital stay at follow for 1 week
Laryngospasm
Time frame: Will be assessed within Hospital stay at follow for 1 week
Bradycardia
Time frame: Will be assessed within Hospital stay at follow for 1 week
Regurgitation
Time frame: Will be assessed within Hospital stay at follow for 1 week
Post operative vomiting and nausea
Time frame: Will be assessed within Hospital stay at follow for 1 week
Hypertension
Time frame: Will be assessed within Hospital stay at follow for 1 week
Hypotension
Time frame: Will be assessed within Hospital stay at follow for 1 week
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 24 Sep 2019.
- Results publication: PubMed 29207810Vaswani JP, Debata D, Vyas V, Pattil S. Comparative Study of the Effect of Dexmedetomidine Vs. Fentanyl on Haemodynamic Response in Patients Undergoing Elective Laparoscopic Surgery. J Clin Diagn Res. 2017 Sep;11(9):UC04-UC08. doi: 10.7860/JCDR/2017/27020.10578. Epub 2017 Sep 1.
- 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.
Sana Urooj, FCPS principal investigator
Dr. Ruth K.M. Pfau Civil Hospital, Karachi
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 and Fentanyl in people with Cholecystectomy and Elective Surgery, run by Dow University of Health Sciences 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 3 inclusion and 7 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 24 Sep 2019. 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?
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?
Systolic blood pressure (time frame: at Baseline). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04089592, which also lists 1 linked publication.
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 24 Sep 2019.