Dexmedetomidine and Laparoscopic Surgery

NCT ID: NCT03172065

Last Updated: 2020-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-07-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Conventionally General anaesthesia remains the choice for the majority of open abdominal surgical procedures, and regional anaesthesia is preferred only for patients who are at high risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the first choice for laparoscopic cases was its advantages over general anaesthesia which include uniform total muscle relaxation, a conscious patient, economical, relatively uneventful recovery, pain free early postoperative period and the protection from potential complications of general anaesthesia. The main debatable point, however, seems to be the status of respiratory parameters among the two modes of anaesthesia during laparoscopic surgery. In this context it can be stated that spontaneous physiological respiration during spinal anaesthesia would always be better than an assisted respiration as in general anaesthesia.

The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml saline

Group Type OTHER

Normal saline

Intervention Type DRUG

intravenous flluid

Dexmedetomidine group

will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml dexmedetomidine (0.5 mic)

Group Type OTHER

Dexmedetomidine

Intervention Type DRUG

anaesthetic adjuvants and pain killer medication.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Normal saline

intravenous flluid

Intervention Type DRUG

Dexmedetomidine

anaesthetic adjuvants and pain killer medication.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Elective gynaecological laparoscopic surgery
* Age 20-45 yrs
* Suspected surgery time 30 minutes
* Inflation pressure \<13 Cm H20

Exclusion Criteria

* Contraindications to regional block (infection at the needle insertion site)
* Altered conscious level.
* Pregnancy
* Body mass index \>35
* Height \<155 cm
* Patients who have difficulty understanding the study protocol
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rasha Hamed

Lecturer of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut university

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IDGL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dexmedetomidine in IVRA
NCT05123170 COMPLETED PHASE4
Dexmedetomidine in Postoperative Analgesia
NCT05705128 ENROLLING_BY_INVITATION PHASE2/PHASE3
Regional Anaesthesia
NCT06055101 COMPLETED NA
Dexamethasone Versus Dexmedetomidine
NCT03064633 COMPLETED PHASE4
Dexmedetomidine Versus Clonidine in TAP Block
NCT03155646 COMPLETED PHASE2/PHASE3