Evaluating Perioperative Outcomes: Dexmedetomidine vs Lignocaine in Laparoscopic Chlolecystectomy

NCT06740903 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 84/IRB/SLMC/SWL
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamics Instability; Post Operative Pain; Gastrointestinal Dysfunction; Cholecystitis

Outcome Measures

Primary Outcomes (3)

• HR

  heart rate of the patient

  heart beats per minute (bpm) before induction of anesthesia, then 5, 10, 20,30, 60,90,120 minutes of anesthesia

• MAP

  Mean Arterial Pressure

  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

  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

  Recovery of postop gastrointestinal function will be assessed using 5 point I-FEED scale at 6, 12, and 24 hours postoperatively

Study Arms (2)

Dexmedetomidine infusion

EXPERIMENTAL

inj dexmedetomidine infusion @ 0.2-0.4 μg/kg/h

Drug: inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h

Lignocaine infusion

EXPERIMENTAL

inj.lignocaine infusion @1-2 mg/kg/h

Drug: inj. lignocaine infusion @1-2 mg/kg/h

Interventions

inj. dexmedetomidine infusion @ 0.2-0.4 μg/kg/h DRUG

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

Also known as: Precedex

Dexmedetomidine infusion

inj. lignocaine infusion @1-2 mg/kg/h DRUG

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

Also known as: Xylocaine

Lignocaine infusion

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of age 20-70 years
• Both gender
• Laparoscopic cholecystectomy under general Anaesthesia
• ASA I-II.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahiwal medical college sahiwal: lead
• Department of medical education: collaborator

Study Sites (1)

Sahiwal Medical College Sahiwal

Sahiwal, Punjab Province, 57000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Cholecystitis

Interventions

Dexmedetomidine; Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Adeel Riaz, MD

  Sahiwal Teaching Hospital, Sahiwal

  STUDY DIRECTOR

Central Study Contacts

Tallal Shahid, MBBS

CONTACT

00923215006215; tallalshahid@hotmail.com

Dr Muhammad Shahid, FCPS

CONTACT

00923336173056; shahidnishtar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Anaesthetist

Study Record Dates

• First Submitted: December 14, 2024
• First Posted: December 18, 2024
• Study Start: August 6, 2024
• Primary Completion: August 6, 2025
• Study Completion: September 6, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

PA (1)