Clinical trial NCT06860100: The Effect of Preoperative Dexmedetomidine and Tramadol on Sedation, Pain and Haemodynamics in Haemorrhoids Patients
Official title: Dexmedetomidine and Tramadol on Perioperative Haemodynamics, Anxiety and Pain in Hemorrhoids Cases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Analgesia
Sedation
Anxiety
Intraoperative Haemodynamics
Keywords: analgesia
sedation
perioperative anxiety
intraoperative aemodynamics
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elective haemorrhoidectomy surgery

Brief summary: To investigate the effects of two different pharmacological agents used for analgesic and sedative purposes on perioperative anxiety and intraoperative haemodynamics in haemorrhoidectomy surgeries.

1. How are the effects of Dexmedetomidine and Tramadol on patient anxiety in the preoperative period?
2. Is there any difference in the evaluation of the efficacy of these drugs on postoperative VAS score?
3. How are the effects of the study drugs on intraoperative haemodynamic data?

Detailed description: The study is planned as a randomised double blind study. The groups will be randomised and divided into two groups by closed envelope method. The person administering the drug and the person who will evaluate the patient will be different and the person making the evaluation will be unaware of which drug is administered to which patient. Preoperative evaluation of the patients included in the study will be performed at least one day before in the Anaesthesiology and Reanimation Polyclinic. Patients between 20-60 years of age, ASA I-II class, who are planned for elective haemorrhoidectomy and whose written and verbal consent is obtained will be included in the study.

Patients who are scheduled for surgery for haemorrhoids and undergo spinal anaesthesia will be included in the case group. However, patients younger than 20 years or older than 60 years, those whose consent could not be obtained, patients with severe renal and hepatic diseases, pregnant women, patients with known allergic response to the agents used and patients with coagulopathy will not be included in the study.

The study is planned as a randomised double blind study. Groups will be randomised by closed envelope method and patients will be divided into 3 groups. The people who administer the drug and the people who evaluate the patient will be different and the evaluator will be unaware of which drug is administered. Preoperative evaluation of the patients included in the study will be performed at least one day before in the Anaesthesiology and Reanimation Polyclinic. A total of 90 patients aged 20-60 years, ASA I-II class, who were planned for elective haemorrhoidectomy and whose written and verbal consent was obtained, will be included in the study.

Patients scheduled for surgery for haemorrhoids and under spinal anaesthesia will be included in the case group. However, patients younger than 20 years or older than 60 years, those whose consent could not be obtained, patients with severe renal and hepatic diseases, pregnant women, patients with known allergic response to the agents used and patients with coagulopathy will not be included in the study.

1. Group C: No drug administration before surgery (30 patients)
2. Group D: Preoperative Dexmedetomidine group (30 patients)
3. Group T: Preoperative Tramadol group (30 patients) STAI anxiety scale, VAS score and pain assessment will be applied to all groups in the preoperative evaluation room.

1-Group C-(Control group): no preoperative drug administration 2-Group D-(Dexmedetomidine group): 1 mcg/kg dexmedetomidine iv infusion 10 minutes loading 3-Group T-(Tramadol group): 1 mg/kg tramadol iv infusion 10 minutes loading All of the groups will undergo subarachnoid saddle block with 1 cc 0.5% bupivacaine heavy in the L4-L5 interval.

Intraoperative haemodynamic parameters (noninvasive blood pressure, SpO2 and heart rate) and sedation requirement will be recorded. For sedation, 1 mg midazolam will be administered intravenously to all groups. Patients will be excluded from the study if the total intraoperative sedation dose exceeds 5 mg. All data will be collected and statistically analysed and the results obtained will be interpreted.

Eligibility criteria: Inclusion Criteria:

* ASA I-II
* 20-60 years
* haemorrhoidectomy to be performed
* written Consent

Exclusion Criteria:

* ASA III and above Under 20 years old - over 60 years old,
* those who cannot be taken written consent
* severe renal and hepatic disease,
* pregnants,
* those with a known allergic response to the agents used
* patients with coagulopathy

Primary outcomes:
measure: STAI
timeFrame: Preoperative
measure: VAS
timeFrame: Preoperative
Secondary outcomes:
measure: haemodynamics
timeFrame: 5 minutes interval
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Van Yuzuncu Yil University School of Medicine Department of Anesthesiology and Reanimation
state: Tuşba
Study officials:
References: