Hemodynamics InstabilityPhase 2/3NCT06740903
Evaluating Perioperative Outcomes: Dexmedetomidine vs Lignocaine in Laparoscopic Chlolecystectomy
A Phase 2/3 study testing inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h and inj. lignocaine infusion @1-2 mg/kg/h in people with Hemodynamics Instability and Post Operative Pain, run by Sahiwal medical college sahiwal at 1 site in Pakistan.
Trial summary
Nowadays laparoscopic surgery is the first choice for many surgeries. Such surgeries have revolutionized the surgical practice and has markedly reduced the incidence of intraoperative and postoperative complications. To minimize these side effects associated with the use of opioids, various methods have been adopted. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamics Instability, Post Operative Pain, Gastrointestinal Dysfunction
- What is being tested?
- inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h and inj. lignocaine infusion @1-2 mg/kg/h
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Aug 2024to 6 Sep 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of age 20-70 years
- Both gender
- Laparoscopic cholecystectomy under general Anaesthesia
- ASA I-II.
Who cannot join
- Emergency surgery
- Patients with history of allergic reaction to trial drugs
- Patients with cardiovascular disease, sickle cell disease, psychiatric disorder, peripheral vascular disease, and neurological diseases (on medical record)
- Anemia
- Patient on TCA or Beta blocker drugs.
- Uncontrolled hypertension (P≥160/100 mmHg)
- Uncontrolled diabetes mellitus
- Obesity BMI > 35
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Sahiwal Medical College Sahiwal
Sahiwal, Punjab Province, 57000
Dr Rao Riaz ul Haq, FCPS, 0092404502470, slmcswl@gmail.com
About this study
Official title: Comparison of Dexmedetomidine & Lignocaine Infusion on Perioperative Hemodynamics, Postoperative Analgesia & Recovery of Postoperative Gastrointestinal Function in Patients for Laparoscopic Cholecystectomy
Nowadays laparoscopic surgery is the first choice for many surgeries. Such surgeries have revolutionized the surgical practice and has markedly reduced the incidence of intraoperative and postoperative complications. To minimize these side effects associated with the use of opioids, various methods have been adopted. Recently, different trials have highlighted the possible role of dexmedetomidine and lignocaine in providing postoperative analgesia and attenuating hemodynamic response. Literature showed conflicting results regarding both these drugs. So, we want to find the evidence for local setting. This Randomized Controlled Trial will be done at Department of Anesthesia, Sahiwal teaching hospital, Sahiwal for 12 months. Sample size of 140 cases; 70 cases in each group will be included through non-probability consecutive sampling. Then patients will be divided in two groups by using computer generated random number table. In group A, patients will be given dexmedetomidine infusion. In group B, patients will be given lignocaine infusion. All anesthesia procedures will be done by researcher. Heart rate and mean arterial pressure will be assessed before induction of anesthesia, after every 10 mins every 30 mins till completion of surgery. Total operative time will be noted. After procedure, patients will be assessed for postoperative pain score. when pain will be ≥4 on visual analogue scale rescue analgesia will be given and time will be noted. Total duration from time of surgery till need for rescue analgesia will be noted. Duration of postoperative analgesia opioid consumption /24 hrs.) will be presented by using mean± SD.
Read the detailed description
After approval from hospital ethical committee and obtaining informed written consent from every patient, patient fulfilling the criteria of inclusion. All patients will be categorized into two different groups using computer generated random number table. Demographic information (name, age, gender, weight, ASA) will be noted. All patients will undergo a preoperative assessment on the day before surgery. They will be pre-medicated with oral midazolam 0.05 mg/kg 2 h before surgery. Anesthesia induction will be done by doing pre-oxygenation for 3 minutes with 100% oxygen, propofol 2-2.5 mg/kg intravenous (IV) and nalbuphine 0.1mg/kg intravenous (IV). Tracheal intubation will be facilitated by succinylcholine 1.5 mg/kg IV. Anaesthesia will be maintained with isoflurane 0.6 mac, 60% nitrous oxide, 40% oxygen, atracurium 0.5mg/kg bolus followed by 0.15mg/kg maintenance dose every 30 mints until completion of surgery. Patients Intraoperative monitoring will include electrocardiogram leads II and V5, non-invasive blood pressure at 5 min intervals, oxygen saturation, end-tidal carbon dioxide and nasopharyngeal temperature. Patients will be ventilated by intermittent positive pressure ventilation using a circle system to maintain normocapnia. In group A, patients will be given inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h intraoperatively. In group B, patients will be given inj. lignocaine infusion @1-2 mg/kg/h intraoperatively. All anesthesia procedures will be done by researcher under supervision of senior consultant anesthesiologist having at least 4years residency experience. The person who will prepare the study drugs will not participate in the data collection procedure. Heart rate and mean arterial pressure will be assessed before induction of anesthesia, then at 5, 10, 20,30, and every 30 minutes till the completion of surgery. Hypotension (MAP <20% of the baseline or <65 mmHg) will be treated with infusion of normal saline and if required injection phenylephrine boluses IV. Bradycardia (HR <40 beats/min) will be treated with IV atropine 40 µg/kg bolus in both intraoperative and post-operative period. All patients will receive paracetamol 15 mg/kg IV and ondansetron 0.1 mg/kg IV ½ hour before the completion of surgery. At the end of surgery, residual neuromuscular block will be antagonized with 0.05mg/kg of neostigmine and glycopyrrolate IV. Tracheal extubation will be performed on meeting the standard criteria for extubating. Total operative time will be noted. After procedure, patients will be shifted in intensive care unit and will be followed-up there for 24 hours. Patients will be assessed for postoperative pain score. when pain will be ≥4 on visual analogue scale rescue analgesia will be given and time will be noted. Total duration from time of surgery till need for rescue analgesia will be noted (as per operational definition). Total opioid consumption /24 hrs. will be noted along with nausea and vomiting. Recovery of postop gastrointestinal function will be assessed using 5 point I-FEED scale at 6, 12, and 24 hours postoperatively. All the information will be recorded on proforma (attached).
- Conditions
- Hemodynamics Instability, Post Operative Pain, Gastrointestinal Dysfunction, Cholecystitis
- Being tested
- inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h, inj. lignocaine infusion @1-2 mg/kg/h
- Medical subject headings
- Pain, Postoperative, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/hDrug
Also called Precedex
Anesthesia induction will be done by doing pre-oxygenation for 3 minutes with 100% oxygen, propofol 2-2.5 mg/kg intravenous (IV) and nalbuphine 0.1mg/kg intravenous (IV). Tracheal intubation will be facilitated by succinylcholine 1.5 mg/kg IV. Anaesthesia will be maintained with isoflurane 0.6 mac, 60% nitrous oxide, 40% oxygen, atracurium 0.5mg/kg bolus followed by 0.15mg/kg maintenance dose every 30 mints until completion of surgery. Patients Intraoperative monitoring will include electrocardiogram leads II and V5, non-invasive blood pressure at 5 min intervals, oxygen saturation, end-tidal carbon dioxide and nasopharyngeal temperature. Patients will be ventilated by intermittent positive pressure ventilation using a circle system to maintain normocapnia. In group A, patients will be given inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h intraoperatively
inj. lignocaine infusion @1-2 mg/kg/hDrug
Also called Xylocaine
Anesthesia induction will be done by doing pre-oxygenation for 3 minutes with 100% oxygen, propofol 2-2.5 mg/kg intravenous (IV) and nalbuphine 0.1mg/kg intravenous (IV). Tracheal intubation will be facilitated by succinylcholine 1.5 mg/kg IV. Anaesthesia will be maintained with isoflurane 0.6 mac, 60% nitrous oxide, 40% oxygen, atracurium 0.5mg/kg bolus followed by 0.15mg/kg maintenance dose every 30 mints until completion of surgery. Patients Intraoperative monitoring will include electrocardiogram leads II and V5, non-invasive blood pressure at 5 min intervals, oxygen saturation, end-tidal carbon dioxide and nasopharyngeal temperature. Patients will be ventilated by intermittent positive pressure ventilation using a circle system to maintain normocapnia. In group A, patients will be given inj. lignocaine infusion @ 1-2 mg/kg/h intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine infusion | Experimental | inj dexmedetomidine infusion @ 0.2-0.4 μg/kg/h Receives: Drug: inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h |
| Lignocaine infusion | Experimental | inj.lignocaine infusion @1-2 mg/kg/h Receives: Drug: inj. lignocaine infusion @1-2 mg/kg/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
HR
heart rate of the patient
Measured: heart beats per minute (bpm) before induction of anesthesia, then 5, 10, 20,30, 60,90,120 minutes of anesthesia
MAP
Mean Arterial Pressure
Measured: it will be measured in terms of mmHg before induction of anesthesia, after 5, 10, 20,30, 60,90,120 minutes of anesthesia on ECG monitor
Post-op Pain
Post Operative Analgesia
Measured: it will be assessed in terms of minuTotal duration from time of surgery till need for rescue analgesia will be noted.
Secondary outcomes (1)
Post-op GIT Functions
Post-operative GIT Functions by I-FEED Scale
Measured: Recovery of postop gastrointestinal function will be assessed using 5 point I-FEED scale at 6, 12, and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start6 Aug 2024
- Primary completion6 Aug 2025 (estimated)
- Study completion6 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamics InstabilityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahiwal medical college sahiwal
- Sponsor type
- Other government
- Collaborators
- Department of medical education
- Responsible party
- Principal investigator, Talal Shahid, Sahiwal medical college sahiwal
- Investigators
- Adeel Riaz, MD, Study director, Sahiwal Teaching Hospital, Sahiwal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740903
- Sponsor's protocol ID
- 84/IRB/SLMC/SWL
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dexmedetomidine & Lignocaine Infusion on Perioperative Hemodynamics, Postoperative Analgesia & Recovery of Postoperative Gastrointestinal Function in Patients for Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06740903
- Acronym / sponsor ID
- 84/IRB/SLMC/SWL
- Conditions
- Hemodynamics Instability, Post Operative Pain, Gastrointestinal Dysfunction, Cholecystitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sahiwal medical college sahiwalOther government
- Collaborators
- Department of medical education
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 6 Aug 2025 (estimated)
- Study completion
- 6 Sep 2025 (estimated)
- First posted
- 18 Dec 2024 (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.
Nowadays laparoscopic surgery is the first choice for many surgeries. Such surgeries have revolutionized the surgical practice and has markedly reduced the incidence of intraoperative and postoperative complications. To minimize these side effects associated with the use of opioids, various methods have been adopted. Recently, different trials have highlighted the possible role of dexmedetomidine and lignocaine in providing postoperative analgesia and attenuating hemodynamic response. Literature showed conflicting results regarding both these drugs. So, we want to find the evidence for local setting. This Randomized Controlled Trial will be done at Department of Anesthesia, Sahiwal teaching hospital, Sahiwal for 12 months. Sample size of 140 cases; 70 cases in each group will be included through non-probability consecutive sampling. Then patients will be divided in two groups by using computer generated random number table. In group A, patients will be given dexmedetomidine infusion. In group B, patients will be given lignocaine infusion. All anesthesia procedures will be done by researcher. Heart rate and mean arterial pressure will be assessed before induction of anesthesia, after every 10 mins every 30 mins till completion of surgery. Total operative time will be noted. After procedure, patients will be assessed for postoperative pain score. when pain will be ≥4 on visual analogue scale rescue analgesia will be given and time will be noted. Total duration from time of surgery till need for rescue analgesia will be noted. Duration of postoperative analgesia opioid consumption /24 hrs.) will be presented by using mean± SD.
Detailed description
After approval from hospital ethical committee and obtaining informed written consent from every patient, patient fulfilling the criteria of inclusion. All patients will be categorized into two different groups using computer generated random number table. Demographic information (name, age, gender, weight, ASA) will be noted. All patients will undergo a preoperative assessment on the day before surgery. They will be pre-medicated with oral midazolam 0.05 mg/kg 2 h before surgery. Anesthesia induction will be done by doing pre-oxygenation for 3 minutes with 100% oxygen, propofol 2-2.5 mg/kg intravenous (IV) and nalbuphine 0.1mg/kg intravenous (IV). Tracheal intubation will be facilitated by succinylcholine 1.5 mg/kg IV. Anaesthesia will be maintained with isoflurane 0.6 mac, 60% nitrous oxide, 40% oxygen, atracurium 0.5mg/kg bolus followed by 0.15mg/kg maintenance dose every 30 mints until completion of surgery. Patients Intraoperative monitoring will include electrocardiogram leads II and V5, non-invasive blood pressure at 5 min intervals, oxygen saturation, end-tidal carbon dioxide and nasopharyngeal temperature. Patients will be ventilated by intermittent positive pressure ventilation using a circle system to maintain normocapnia. In group A, patients will be given inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h intraoperatively. In group B, patients will be given inj. lignocaine infusion @1-2 mg/kg/h intraoperatively. All anesthesia procedures will be done by researcher under supervision of senior consultant anesthesiologist having at least 4years residency experience. The person who will prepare the study drugs will not participate in the data collection procedure. Heart rate and mean arterial pressure will be assessed before induction of anesthesia, then at 5, 10, 20,30, and every 30 minutes till the completion of surgery. Hypotension (MAP <20% of the baseline or <65 mmHg) will be treated with infusion of normal saline and if required injection phenylephrine boluses IV. Bradycardia (HR <40 beats/min) will be treated with IV atropine 40 µg/kg bolus in both intraoperative and post-operative period. All patients will receive paracetamol 15 mg/kg IV and ondansetron 0.1 mg/kg IV ½ hour before the completion of surgery. At the end of surgery, residual neuromuscular block will be antagonized with 0.05mg/kg of neostigmine and glycopyrrolate IV. Tracheal extubation will be performed on meeting the standard criteria for extubating. Total operative time will be noted. After procedure, patients will be shifted in intensive care unit and will be followed-up there for 24 hours. Patients will be assessed for postoperative pain score. when pain will be ≥4 on visual analogue scale rescue analgesia will be given and time will be noted. Total duration from time of surgery till need for rescue analgesia will be noted (as per operational definition). Total opioid consumption /24 hrs. will be noted along with nausea and vomiting. Recovery of postop gastrointestinal function will be assessed using 5 point I-FEED scale at 6, 12, and 24 hours postoperatively. All the information will be recorded on proforma (attached).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine infusion | Experimental | Drug: inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/hinj dexmedetomidine infusion @ 0.2-0.4 μg/kg/h |
| Lignocaine infusion | Experimental | Drug: inj. lignocaine infusion @1-2 mg/kg/hinj.lignocaine infusion @1-2 mg/kg/h |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of age 20-70 years
- Both gender
- Laparoscopic cholecystectomy under general Anaesthesia
- ASA I-II.
Key exclusion criteria (8 listed)
- Emergency surgery
- Patients with history of allergic reaction to trial drugs
- Patients with cardiovascular disease, sickle cell disease, psychiatric disorder, peripheral vascular disease, and neurological diseases (on medical record)
- Anemia
- Patient on TCA or Beta blocker 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 |
|---|---|---|
| inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/hAlso: PrecedexAnesthesia induction will be done by doing pre-oxygenation for 3 minutes with 100% oxygen, propofol 2-2.5 mg/kg intravenous (IV) and nalbuphine 0.1mg/kg intravenous (IV). Tracheal intubation will be facilitated by succinylcholine 1.5 mg/kg IV. Anaesthesia will be maintained with isoflurane 0.6 mac, 60% nitrous oxide, 40% oxygen, atracurium 0.5mg/kg bolus followed by 0.15mg/kg maintenance dose every 30 mints until completion of surgery. Patients Intraoperative monitoring will include electrocardiogram leads II and V5, non-invasive blood pressure at 5 min intervals, oxygen saturation, end-tidal carbon dioxide and nasopharyngeal temperature. Patients will be ventilated by intermittent positive pressure ventilation using a circle system to maintain normocapnia. In group A, patients will be given inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h intraoperatively | Drug | Dexmedetomidine infusion |
| inj. lignocaine infusion @1-2 mg/kg/hAlso: XylocaineAnesthesia induction will be done by doing pre-oxygenation for 3 minutes with 100% oxygen, propofol 2-2.5 mg/kg intravenous (IV) and nalbuphine 0.1mg/kg intravenous (IV). Tracheal intubation will be facilitated by succinylcholine 1.5 mg/kg IV. Anaesthesia will be maintained with isoflurane 0.6 mac, 60% nitrous oxide, 40% oxygen, atracurium 0.5mg/kg bolus followed by 0.15mg/kg maintenance dose every 30 mints until completion of surgery. Patients Intraoperative monitoring will include electrocardiogram leads II and V5, non-invasive blood pressure at 5 min intervals, oxygen saturation, end-tidal carbon dioxide and nasopharyngeal temperature. Patients will be ventilated by intermittent positive pressure ventilation using a circle system to maintain normocapnia. In group A, patients will be given inj. lignocaine infusion @ 1-2 mg/kg/h intraoperatively | Drug | Lignocaine infusion |
Primary outcome
HR
Time frame: heart beats per minute (bpm) before induction of anesthesia, then 5, 10, 20,30, 60,90,120 minutes of anesthesia
heart rate of the patient
MAP
Time frame: it will be measured in terms of mmHg before induction of anesthesia, after 5, 10, 20,30, 60,90,120 minutes of anesthesia on ECG monitor
Mean Arterial Pressure
Post-op Pain
Time frame: it will be assessed in terms of minuTotal duration from time of surgery till need for rescue analgesia will be noted.
Post Operative Analgesia
1 secondary outcome
Post-op GIT Functions
Time frame: Recovery of postop gastrointestinal function will be assessed using 5 point I-FEED scale at 6, 12, and 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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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.
Adeel Riaz, MD study director
Sahiwal Teaching Hospital, Sahiwal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h and inj. lignocaine infusion @1-2 mg/kg/h in people with Hemodynamics Instability and Post Operative Pain, run by Sahiwal medical college sahiwal at 1 site 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Dec 2024. 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tallal Shahid, MBBS (00923215006215, tallalshahid@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HR (time frame: heart beats per minute (bpm) before induction of anesthesia, then 5, 10, 20,30, 60,90,120 minutes of anesthesia). The study lists 3 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 18 Dec 2024.