Evaluating Perioperative Outcomes: Dexmedetomidine vs Lignocaine in Laparoscopic Chlolecystectomy

Phase 2

Recruiting

• Conditions: Hemodynamics Instability; Post Operative Pain; Gastrointestinal Dysfunction; Cholecystitis
• Interventions: Drug: inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h; Drug: inj. lignocaine infusion @1-2 mg/kg/h

• Registration Number: NCT06740903
• Lead Sponsor: Sahiwal medical college sahiwal

Brief 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. 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 Timeline

• Study Start: 2024-08-06
• Status Verified: 2024-12
• Study First Submitted: 2024-12-14
• Study First Submitted QC: 2024-12-14
• Last Update Submitted: 2024-12-14
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-08-06
• Study Completion: 2025-09-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Patients of age 20-70 years
2. Both gender
3. Laparoscopic cholecystectomy under general Anaesthesia
4. ASA I-II.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine infusion	inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h	inj dexmedetomidine infusion @ 0.2-0.4 μg/kg/h
Lignocaine infusion	inj. lignocaine infusion @1-2 mg/kg/h	inj.lignocaine infusion @1-2 mg/kg/h

Primary Outcome Measures

Name	Time	Method
HR	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	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	it will be assessed in terms of minuTotal duration from time of surgery till need for rescue analgesia will be noted.	Post Operative Analgesia

Secondary Outcome Measures

Name	Time	Method
Post-op GIT Functions	Recovery of postop gastrointestinal function will be assessed using 5 point I-FEED scale at 6, 12, and 24 hours postoperatively	Post-operative GIT Functions by I-FEED Scale

Trial Locations

Locations (1)

Sahiwal Medical College Sahiwal; 🇵🇰 Sahiwal, Punjab, Pakistan