Evaluating Perioperative Outcomes: Dexmedetomidine vs Lignocaine in Laparoscopic Chlolecystectomy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age20-70
SponsorSahiwal medical college sahiwal
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients of age 20-70 years
Both gender
Laparoscopic cholecystectomy under general Anaesthesia
ASA I-II.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h
DrugAnesthesia 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/h
DrugAnesthesia 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
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Dexmedetomidine infusionExperimental treatment 1 intervention
Group B: Lignocaine infusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
HR
heart rate of the patient
Time frame
heart beats per minute (bpm) before induction of anesthesia, then 5, 10, 20,30, 60,90,120 minutes of anesthesia2
MAP
Mean Arterial Pressure
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 monitor3
Post-op Pain
Post Operative Analgesia
Time frame
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
Time frame
Recovery of postop gastrointestinal function will be assessed using 5 point I-FEED scale at 6, 12, and 24 hours postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Sahiwal medical college sahiwal
Lead sponsor
Department of medical education
Collaborator
Source ClinicalTrials.gov