AzTrials
AzTrials

Laparoscopic Cholecystectomy SurgeryPhase 3NCT06838650

Beneficial Effects of Low-Dose Intravenous Dexmedetomidine Premedication in Patient Undergoing Laparoscopic Cholecystectomy Under General Anesthesia

A Phase 3 study testing Dexmedetomidine and Saline in people with Laparoscopic Cholecystectomy Surgery, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

Search all trials

Trial summary

Laparoscopic cholecystectomy (LC) is considered the standard treatment for gallbladder disease.1 Compared to open cholecystectomy, LC is the preferred treatment approach because it is associated with less surgical trauma, shorter hospital stays, and faster postoperative recovery.2 However, the elevated intra-abdominal… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Laparoscopic Cholecystectomy Surgery
What is being tested?
Dexmedetomidine and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
No sites listed yet
Study dates
1 Mar 2025to 1 Jun 2026
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • age 18-64 years with planned LC
  • American Society of Anesthesiologists (ASA) physical status of Grade I or II
  • body mass index (BMI) of 20-30 kg/m2 .

Who cannot join

  • severe cardiovascular
  • cerebrovascular disease
  • severe endocrine
  • liver, kidney
  • neurological
  • blood system disease
Show all 14Show fewer
  • preoperative respiratory infection or asthma
  • history of opioid addiction
  • allergy to the drugs used in this study
  • psychosocial disease or cognitive dysfunction.
  • incomplete case report form or lost to follow-up and failed to undergo an effectiveness and safety assessment
  • LC converted to open surgery
  • severe hemodynamic instability during surgery
  • surgical duration >2 h .

About this study

Laparoscopic cholecystectomy (LC) is considered the standard treatment for gallbladder disease.1 Compared to open cholecystectomy, LC is the preferred treatment approach because it is associated with less surgical trauma, shorter hospital stays, and faster postoperative recovery.2 However, the elevated intra-abdominal pressure due to pneumoperitoneum can cause various stress responses that affect patient prognosis and present a severe challenge in anesthetic management.3 Therefore, the search for an optimal anesthetic protocol to minimize adverse reactions during LC remains critical.

Dexmedetomidine (Dex), a potent and highly selective α2-adrenergic receptor agonist, presents sedative, analgesic, anesthetic, and sympatholytic properties, without causing respiratory depression, when used in an appropriate dose range.4 Numerous studies have suggested that Dex can effectively attenuate the surgical stress response and provide intraoperative hemodynamic stability.5 Furthermore, it has been shown to reduce anesthetic requirements and improve the quality of patient recovery.6,7 Hence, it has been widely used as an adjuvant during general anesthesia.

Nevertheless, the clinical effects of Dex remain controversial. Some studies have shown that the anesthesia recovery time is prolonged and the incidence of bradycardia increases significantly after intravenous Dex infusion.8-10 This is mainly attributed to the different doses and methods of Dex administration. Although the complications are always transient and reversible, timely attention is required to avoid serious adverse consequences. To enhance the value of Dex for clinical application and improve the quality of general anesthesia, the more appropriate protocol of Dex administra- tion need to be explored. The elimination half-life of Dex is approximately 2 h, with a rapid distribution half-life of approximately 6 min.11 Most LC procedures are completed within 1 h; therefore, to reduce postoperative complications and shorten postoperative recovery time, we prefer preoperative Dex loading to intraoperative continuous Dex infusion. According to our previous data, the anesthesia awakening time will be prolonged and the incidence of bradycardia increased significantly when 1.0 µg/kg of Dex will be administered before general anesthesia induction. This prospective, double-blind, randomized controlled trial aimed to determine the efficacy of low-dose (0.5 µg/kg) intravenous Dex premedication on hemodynamics and adverse events during general anesthesia. We aimed to confirm the efficacy of low- dose intravenous Dex premedication in patients under general anesthesia during LC and to provide a data reference for the clinical application of Dex in further research. Dexmedetomidine (Dex) is a potent and highly selective α2-adrenergic receptor agonist. Within an appropriate dose range, Dex can effectively attenuate the surgical stress response, provide intraoperative hemodynamic stability, and improve the patient recovery quality. High-dose Dex can delay patient awakening from anesthesia and increase the incidence of bradycardia. This randomized controlled trial aimed to investigate the effects of low-dose intravenous Dex premedication in patients undergoing laparoscopic cholecystectomy (LC).

Read the detailed description

Laparoscopic cholecystectomy (LC) is considered the standard treatment for gallbladder disease.1 Compared to open cholecystectomy, LC is the preferred treatment approach because it is associated with less surgical trauma, shorter hospital stays, and faster postoperative recovery.2 However, the elevated intra-abdominal pressure due to pneumoperitoneum can cause various stress responses that affect patient prognosis and present a severe challenge in anesthetic management.3 Therefore, the search for an optimal anesthetic protocol to minimize adverse reactions during LC remains critical.

Dexmedetomidine (Dex), a potent and highly selective α2-adrenergic receptor agonist, presents sedative, analgesic, anesthetic, and sympatholytic properties, without causing respiratory depression, when used in an appropriate dose range.4 Numerous studies have suggested that Dex can effectively attenuate the surgical stress response and provide intraoperative hemodynamic stability.5 Furthermore, it has been shown to reduce anesthetic requirements and improve the quality of patient recovery.6,7 Hence, it has been widely used as an adjuvant during general anesthesia.

Nevertheless, the clinical effects of Dex remain controversial. Some studies have shown that the anesthesia recovery time is prolonged and the incidence of bradycardia increases significantly after intravenous Dex infusion.8-10 This is mainly attributed to the different doses and methods of Dex administration. Although the complications are always transient and reversible, timely attention is required to avoid serious adverse consequences. To enhance the value of Dex for clinical application and improve the quality of general anesthesia, the more appropriate protocol of Dex administra- tion need to be explored. The elimination half-life of Dex is approximately 2 h, with a rapid distribution half-life of approximately 6 min.11 Most LC procedures are completed within 1 h; therefore, to reduce postoperative complications and shorten postoperative recovery time, we prefer preoperative Dex loading to intraoperative continuous Dex infusion. According to our previous data, the anesthesia awakening time will be prolonged and the incidence of bradycardia increased significantly when 1.0 µg/kg of Dex will be administered before general anesthesia induction. This prospective, double-blind, randomized controlled trial aimed to determine the efficacy of low-dose (0.5 µg/kg) intravenous Dex premedication on hemodynamics and adverse events during general anesthesia. We aimed to confirm the efficacy of low- dose intravenous Dex premedication in patients under general anesthesia during LC and to provide a data reference for the clinical application of Dex in further research. Dexmedetomidine (Dex) is a potent and highly selective α2-adrenergic receptor agonist. Within an appropriate dose range, Dex can effectively attenuate the surgical stress response, provide intraoperative hemodynamic stability, and improve the patient recovery quality. High-dose Dex can delay patient awakening from anesthesia and increase the incidence of bradycardia. This randomized controlled trial aimed to investigate the effects of low-dose intravenous Dex premedication in patients undergoing laparoscopic cholecystectomy (LC).

Being tested
Dexmedetomidine, Saline
Keywords
Dexmedetomidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    patients will recive of low-dose (0.5 µg/kg) intravenous Dexmedetomidine before general anathesia

  • SalineDrug

    patients will recive saline

Study groups in NCT06838650
Study groupRoleWhat they receive
Group APlacebo comparatorpatients undergoing laparoscobic cholestotectomy will be premedicated with saline . The patients will be premedicated before anesthesia induction
Receives: Drug: Saline
Group BActive comparatorpatients undergoing LC will be premedication with 0.5 µg/kg Dex. The patients will be premedicated before anesthesia induction
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the incidence of bradycardia

    heart rate of study patients will be recorded every 5 min during surgery and every 1 hour postoperative

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06838650
Sponsor's protocol ID
LD Dex premedication LC
Status last verified
Feb 2025
First submitted
19 Feb 2025
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in