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NCT Number: NCT06879288

Dexmedetomidine Versus Magnesium Sulfate as Adjuvants to Intraperitoneal Bupivacaine for Postoperative Analgesia After Elective Laparoscopic Cholecystectomy

This study aimed to assess the efficiency of dexmedetomidine against magnesium sulfate as adjuvants to intraperitoneal bupivacaine for postoperative analgesia in individuals having elective laparoscopic cholecystectomy.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Pain after laparoscopy is less intense than after laparotomy, but laparoscopy is not pain free and analgesia after this type of surgery is inadequately studied. Intraperitoneal (IP) instillation/nebulization of local anesthetics has been used as a method for reducing postoperative pain and opioid use following laparoscopy through acting on visceral nociceptors of the peritoneum.

Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks. It is available mixed with a small amount of epinephrine to increase the duration of its action. It typically begins working within 15 minutes and lasts for 2 to 8 hours.

Dexmedetomidine is a selective alpha-2 (α2) adrenergic agonist known to have analgesic and sedative characteristics that can augment the duration of action of local anesthetics.

Magnesium is an N-methyl-D-aspartate receptor antagonist in addition to its effects on calcium influx. The anti-inflammatory and opioid-sparing effects make it a popular component of opioid free anaesthesia. It is extensively used for perioperative analgesia in a dose of 30- to 50-mg/kg intravascular bolus followed by a 10- to 15-mg/kg/h infusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 21 to 65 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) class I-III.
  • Scheduled to undergo elective laparoscopic cholecystectomy.

Exclusion criteria

  • Patient refusal.
  • Body mass index ≥40.
  • Allergy to the study drugs.
  • Advanced cardiac, renal and hepatic diseases.
  • Patients with peritoneal drain or peritoneal wash after surgery.
  • Uncooperative patients.
  • Chronic pain medications.
  • Hypomagnesaemia or hypermagnesaemia.

Treatment and study plan

Bupivacaine

Drug

Patients received intraperitoneal bupivacaine only at the end of the operations.

Dexmedetomidine

Drug

Patients received intraperitoneal bupivacaine plus dexmedetomidine at the end of the operations.

Magnesium sulfate

Drug

Patients received intraperitoneal bupivacaine plus magnesium sulfate at the end of the operations.

Primary outcomes

  1. Degree of pain

    Time frame: 24 hours postoperatively

    Degree of pain was assessed using the numerical rating score (NRS) (from 0 = no pain, to 10 = the most severe pain).NRS was assessed at 1, 2, 4, 8, 16, and 24 hours postoperative.

Secondary outcomes

  1. Time to the first rescue analgesia request

    Time frame: 24 hours postoperatively

    Time to the first rescue analgesia request (time from the end of surgery till first dose of morphine administrated)

  2. Total morphine consumption

    Time frame: 24 hours postoperatively

    If Numerical rating score (NRS)-S >4, IV 3 mg morphine was given as a rescue analgesia.

  3. Level of sedation

    Time frame: 24 hours postoperatively

    Level of sedation using Ramsey scale at 1, 2, 4, 8, 16, and 24 hours postoperative from 1 to 6:

    • Patient is anxious and agitated.
    • Patient is co-operative and oriented.
    • Patient responds to commands only.
    • Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.
    • Patient exhibits sluggish response to light glabellar tap or loud auditory stimulus.
    • Patient exhibits no response.
  4. Lenght of hospital stay

    Time frame: 1 week postoperatively

    Length of hospital stay was recorded from admission till discharge from hospital.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Efficacy of Dexmedetomidine Versus Magnesium Sulfate as Adjuvants to Intraperitoneal Bupivacaine for Postoperative Analgesia in Patients Undergoing Elective Laparoscopic Cholecystectomy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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