Comparison between intravenous Dexmedetomidine versus Nalbuphine in Reducing Hemodynamic Stress Responses to Intubation in Laparoscopic Surgeries.

A prospective randomised comparative study to compare the efficacy of intravenous Dexmedetomedine versus Nalbuphine in attenuating hemodynamic stress responses during laryngoscopy endotracheal intubation and pneumoperitoneum in laparoscopic surgeries under general anaesthesia. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080819

Enrollment

Registered

2025-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Intravenous Dexmedetomidine 1mcg/kg: Inj. Dexmedetomidine 1mcg/kg diluted in 10ml normal saline 10 minutes prior to induction of general anaesthesia observed over 24 hours post operativ

Eligibility

Inclusion criteria

Inclusion criteria: Patients voluntarily willing to sign informed consent. Male or female patients between 18 to 60 years of age. Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II. Patients posted for elective laparoscopic surgeries under general anaesthesia.

Exclusion criteria

Exclusion criteria: Patients unwilling to participate in the study. Patients belonging to American Society of Anesthesiologists (ASA) physical status III & IV. Patients who are a known case and on treatment for Hypertension and/or Diabetes Mellitus. Patients with anticipated difficult airway and difficult intubation. Patients with Body Mass Index = 30 kg/m2. Patients with history of muscular disorder; myositis; or any local infection. Patients with cardiovascular diseases, arrhythmias, heart blocks, or taking beta blockers. Patients with cerebrovascular, hepatic and renal diseases. Patients with history of allergy to an a-2 adrenergic agonist and opioid drugs. Pregnant & lactating women. Patient whose laparoscopic surgery gets converted into open surgery due to any unforeseen complications.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of intravenous Dexmedetomedine versus Nalbuphine on attenuating hemodynamic stress response to laryngoscopy for endotracheal intubation and pneumoperitoneum in patients undergoing elective laparoscopic surgeries under general anaesthesia.Timepoint: Baseline After test drug administration Before induction At laryngoscope and intubation - 0 min After intubation 1 min 3 min 5 min 10 min 15 min 20 min 30 min 45 min 60 min 90 min 120 min 150 min 180 min	—

Measure

Time frame

To compare the efficacy of intravenous Dexmedetomedine versus Nalbuphine on attenuating hemodynamic stress response to laryngoscopy for endotracheal intubation and pneumoperitoneum in patients undergoing elective laparoscopic surgeries under general anaesthesia.Timepoint: Baseline After test drug administration Before induction At laryngoscope and intubation - 0 min After intubation 1 min 3 min 5 min 10 min 15 min 20 min 30 min 45 min 60 min 90 min 120 min 150 min 180 min

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Secondary

Measure	Time frame
To compare the post operative hemodynamic stress response.Timepoint: Hours Post-Operatively 1 hour 2 hours 4 hours 6 hours 12 hours 24 hours;To compare the post operative sedation using Ramsay Sedation Score and analgesia using Visual Analogue Score and rescue analgesia required in 24 hours post operatively.Timepoint: Hours Post-Operatively 1 hour 2 hours 4 hours 6 hours 12 hours 24 hours;To compare pos-operative complications if any.Timepoint: During 24 hours period post-operatively.	—

Measure

Time frame

To compare the post operative hemodynamic stress response.Timepoint: Hours Post-Operatively 1 hour 2 hours 4 hours 6 hours 12 hours 24 hours;To compare the post operative sedation using Ramsay Sedation Score and analgesia using Visual Analogue Score and rescue analgesia required in 24 hours post operatively.Timepoint: Hours Post-Operatively 1 hour 2 hours 4 hours 6 hours 12 hours 24 hours;To compare pos-operative complications if any.Timepoint: During 24 hours period post-operatively.

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Countries

India

Contacts

Public ContactDr Jatin Patel

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

dr_jatinpatel@yahoo.co.in9879368363

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026